TRANSRADIAL ARTERY ACCESS DEVICES
FDA 510(k) clearance K112554 · decided 2011-11-18
Clearance details
- K-number
- K112554
- Device name
- TRANSRADIAL ARTERY ACCESS DEVICES
- Applicant
- Teleflexmedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-09-02
- Decision date
- 2011-11-18
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Reading, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used recall (Z-0468-2014) | Arrow International Inc | 2013-12-09 |