CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
FDA 510(k) clearance K023880 · decided 2002-12-11
Clearance details
- K-number
- K023880
- Device name
- CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-11-21
- Decision date
- 2002-12-11
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Somerville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards Lifescien recall (Z-2777-2011) | Edwards Lifesciences, LLC | 2011-07-11 |
| Steerable Coronary Sinus Catheter Kit, REF SCS01, 9 Fr x 20.4", Contains Phthalates, Steri recall (Z-0992-2011) | Edwards Lifesciences Llc | 2011-01-28 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ETHIZIA (P240035) | ETHICON, Inc. | 2025-12-15 |
| INTERCEED Absorbable Adhesion Barrier (P880047/S068) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S127) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S122) | ETHICON, Inc. | 2025-11-04 |
| SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7. (N12159/S126) | ETHICON, Inc. | 2025-10-09 |
| GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5. (P880047/S067) | ETHICON, Inc. | 2025-10-09 |
| SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder (N12159/S125) | ETHICON, Inc. | 2025-09-24 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S066) | ETHICON, Inc. | 2025-09-24 |