TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE
FDA 510(k) clearance K934901 · decided 1994-01-21
Clearance details
- K-number
- K934901
- Device name
- TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE
- Applicant
- Thomas Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-14
- Decision date
- 1994-01-21
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
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