Route 92 Medical Sheath System— 510(k) K191717
Substantially EquivalentRoute 92 Medical, Inc.
FDA 510(k) clearance K191717 for Route 92 Medical Sheath System, Substantially Equivalent on 2020-01-13. Applicant: Route 92 Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Route 92 Medical, Inc.
- Product code
- Code DQY
- 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 DQY
view allMore clearances from Route 92 Medical, Inc.
view all- 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
- K223530 — Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
Adverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
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.