INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8
FDA 510(k) clearance K960883 · decided 1996-03-20
Clearance details
- K-number
- K960883
- Device name
- INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8
- Applicant
- Taut, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-03-05
- Decision date
- 1996-03-20
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Geneva, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Taut Intraducer Peritoneal Catheter, 12 Fr x 10 Fr x 20.3 cm; a sterile, Rx peritoneal cat recall (Z-0428-2007) | Taut, Inc. | 2007-02-15 |