PERCUTANEOUS INTRODUCER SYSTEM
FDA 510(k) clearance K961219 · decided 1996-06-21
Clearance details
- K-number
- K961219
- Device name
- PERCUTANEOUS INTRODUCER SYSTEM
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1996-03-28
- Decision date
- 1996-06-21
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- GEH
- Device class
- 2
- Regulation number
- 878.4350
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
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