INTRODUCER SHEATH AND DILATOR
FDA 510(k) clearance K971165 · decided 1997-07-23
Clearance details
- K-number
- K971165
- Device name
- INTRODUCER SHEATH AND DILATOR
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1997-03-31
- Decision date
- 1997-07-23
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- LDF
- Device class
- 2
- Regulation number
- 870.3680
- 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
No recalls on record reference this clearance.