INTRODUCER SHEATH
FDA 510(k) clearance K001328 · decided 2000-07-17
Clearance details
- K-number
- K001328
- Device name
- INTRODUCER SHEATH
- Applicant
- Novasys Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-04-26
- Decision date
- 2000-07-17
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- FEC
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OBTURATOR, DEFLECTING (K760183) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-02 |
| OBTURATOR, VISUAL (K760172) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-02 |
Recalls involving this device
No recalls on record reference this clearance.