MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM
FDA 510(k) clearance K952828 · decided 1995-08-18
Clearance details
- K-number
- K952828
- Device name
- MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1995-06-20
- Decision date
- 1995-08-18
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- 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 |
|---|---|---|
| Boston Scientific ACCUSTICK II Introducer System with .038 inch Stainless Steel J Tip and recall (Z-0328-2008) | Boston Scientific Corp | 2007-12-07 |