TriSalus TriNav Advance Infusion System (K253509): 510(k) cleared for Trisalus Life Sciences
TriSalus TriNav Advance Infusion System (K253509): 510(k) cleared for Trisalus Life Sciences (Colorado): 510(k) cleared for Trisalus Life Sciences. Its amount of 320 is top-decile (96th percentile of 414 records). Dated 44 days ago, it serves as a historical benchmark. Score 66/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 320 · 96th percentile of 414 FDAPulse records · 2.3x the median
Free preview: all 14 published fields of this record are shown below. Locked: 8 related CO FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K253509 |
| Device | TriSalus TriNav Advance Infusion System |
| Applicant | Trisalus Life Sciences |
| Specialty / panel | Cardiovascular |
| Product code | KRA |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-11-05 |
| Decision date | 2026-09-21 |
| Review time (days) | 320 |
| Third-party review | Yes |
| Applicant location | Westminster, CO, US |
| amount percentile | 96th of 414 (median 138, 2.3x median) |
| Peer records CSV (9 CO records) | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-21
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: TriSalus TriNav Advance Infusion System (K253509): 510(k) cleared for Trisalus Life Sciences and 9 Colorado peers
- Colorado FDAPulse records like this one: 9
- TriSalus TriNav Advance Infusion System (K253509): 510(k) cleared for Trisalus Life Sciences's amount: 96th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Colorado peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
66 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 320-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Reviewed through the third-party program.
- Posted 44 days ago.
What is the FDAPulse record for TriSalus TriNav Advance Infusion System (K253509): 510(k) cleared for Trisalus Life Sciences in Colorado?
TriSalus TriNav Advance Infusion System (K253509) by Trisalus Life Sciences was cleared on 2026-09-21 after 320 days of review.
How does TriSalus TriNav Advance Infusion System (K253509): 510(k) cleared for Trisalus Life Sciences compare to other Colorado FDAPulse records?
This is a top-decile record: its amount of 320 is 2.3x the median of 138 across 414 records. It is 44 days old, still within a typical 45-day follow-up window.
TriSalus TriNav Advance Infusion System (K253509) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| TriSalus TriNav Advance Infusion System (K253509) | CO | 2026-09-21 |
| Hemotag Analysis Software (HAS) (K252736) | FL | 2026-10-21 |
| Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168) | TX | 2026-10-16 |
| eClinics (K260075) | NY | 2026-10-07 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Cardiovascular devices
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