COAXIAL DILATOR SET
FDA 510(k) clearance K000737 · decided 2000-08-01
Clearance details
- K-number
- K000737
- Device name
- COAXIAL DILATOR SET
- Applicant
- Xentek Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-03-07
- Decision date
- 2000-08-01
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- DRE
- Device class
- 2
- Regulation number
- 870.1310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Athens, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-0 recall (Z-2917-2026) | Galt Medical Corporation | 2026-08-07 |
| B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 recall (Z-1732-2025) | Galt Medical Corporation | 2025-05-07 |
| Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Vascular recall (Z-1592-2010) | Galt Medical Corp | 2010-05-11 |