TRANS-CATHETER EXTRACTOR
FDA 510(k) clearance K063048 · decided 2007-09-14
Clearance details
- K-number
- K063048
- Device name
- TRANS-CATHETER EXTRACTOR
- Applicant
- Tran Pa-C, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-04
- Decision date
- 2007-09-14
- Days to decision
- 345 days
- Clearance type
- Traditional
- Product code
- ODY
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Orlando, FL, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Produc recall (Z-2559-2024) | Merit Medical Systems, Inc. | 2024-08-12 |