BIP-COAX-SYSTEM
FDA 510(k) clearance K915801 · decided 1994-03-11
Clearance details
- K-number
- K915801
- Device name
- BIP-COAX-SYSTEM
- Applicant
- Uni-Quatro Industries Canada, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-12-24
- Decision date
- 1994-03-11
- Days to decision
- 808 days
- Clearance type
- Traditional
- Product code
- FCG
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Niagara Falls, Ontario, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet, Catalo recall (Z-0913-06) | Bard Peripheral Vascular Inc | 2006-05-31 |