COAXIAL DILATOR SET
FDA 510(k) clearance K974640 · decided 1998-03-13
Clearance details
- K-number
- K974640
- Device name
- COAXIAL DILATOR SET
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1997-12-15
- Decision date
- 1998-03-13
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- DRE
- Device class
- 2
- Regulation number
- 870.1310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (4 F recall (Z-0759-04) | Boston Scientific Corporation | 2004-07-20 |