EXACTA PERCUTANEOUS INTRODUCER SHEATH
FDA 510(k) clearance K941428 · decided 1994-07-06
Clearance details
- K-number
- K941428
- Device name
- EXACTA PERCUTANEOUS INTRODUCER SHEATH
- Applicant
- Ohmeda Medical
- Decision
- Substantially Equivalent
- Date received
- 1994-03-24
- Decision date
- 1994-07-06
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Oxnard, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Exacta 8.5 Fr Percutaneous Sheath Introducer Tray recall (Z-0628-05) | Becton Dickinson Infusion Therapy | 2005-03-18 |
| BD Exacta 6Fr Percutaneous Sheath Introducer Tray. recall (Z-0631-05) | Becton Dickinson Infusion Therapy | 2005-03-18 |