DAIG OBTURATOR, CATHETER INTRODUCER
FDA 510(k) clearance K884494 · decided 1989-02-22
Clearance details
- K-number
- K884494
- Device name
- DAIG OBTURATOR, CATHETER INTRODUCER
- Applicant
- Daig Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-10-25
- Decision date
- 1989-02-22
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 recall (Z-0125-06) | St. Jude Medical / Daig Division | 2005-11-03 |