ANGEION HEMOSTASIS VALVE INTRODUCER
FDA 510(k) clearance K894446 · decided 1989-11-30
Clearance details
- K-number
- K894446
- Device name
- ANGEION HEMOSTASIS VALVE INTRODUCER
- Applicant
- Angeion Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-17
- Decision date
- 1989-11-30
- Days to decision
- 136 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Locking Tear-Away Sheath Introducer Product Line. ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/ recall (Z-1062-05) | B. Braun Medical, Inc. | 2005-08-03 |