CROSSOVER
FDA 510(k) clearance K083269 · decided 2009-02-03
Clearance details
- K-number
- K083269
- Device name
- CROSSOVER
- Applicant
- Thomas Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-05
- Decision date
- 2009-02-03
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis recall (Z-0120-2010) | Thomas Medical Products Inc | 2009-11-24 |
| Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Gre recall (Z-0087-2010) | Cordis Corporation | 2009-11-05 |