Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set— 510(k) K263266
Substantially EquivalentRoute 92 Medical, Inc.
FDA 510(k) clearance K263266 for Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set, Substantially Equivalent on 2026-10-16. 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
- Special
- Location
- San Mateo, CA, US
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More clearances from Route 92 Medical, Inc.
view all- K260220 — Route 92 Medical Full Length 046 Access System
- K243601 — Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
- 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
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.