Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set— 510(k) K243601
Substantially EquivalentRoute 92 Medical, Inc.
FDA 510(k) clearance K243601 for Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set, Substantially Equivalent on 2025-05-19. Applicant: Route 92 Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Route 92 Medical, Inc.
- Product code
- Product code NRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Mateo, CA, US
Recent devices under product code NRY
view all- K262021 — Toro 71 Aspiration Catheter; Toro Aspiration Tubing
- K263266 — Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set
- K261089 — Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit
- K260617 — Tigertriever 13 Ultra Revascularization Device
- K262398 — CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set
More clearances from Route 92 Medical, Inc.
view all- K260220 — Route 92 Medical Full Length 046 Access System
- K240529 — 8F Modified Sheath System
- K233329 — Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
- K231583 — Route 92 Medical Full Length 054 Access System
- K223530 — Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
Adverse events under product code NRY
product code NRY- Death
- 411
- Injury
- 1,712
- Malfunction
- 1,855
- Total
- 3,978
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.