CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS
FDA 510(k) clearance K120158 · decided 2012-08-14
Clearance details
- K-number
- K120158
- Device name
- CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS
- Applicant
- Thomas Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-01-18
- Decision date
- 2012-08-14
- Days to decision
- 209 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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| Record | Firm | Date |
|---|---|---|
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Produc recall (Z-2571-2024) | Merit Medical Systems, Inc. | 2024-08-12 |
| Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Produc recall (Z-2577-2024) | Merit Medical Systems, Inc. | 2024-08-12 |