2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035
FDA 510(k) clearance K123632 · decided 2013-01-25
Clearance details
- K-number
- K123632
- Device name
- 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035
- Applicant
- Spectranetics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2012-11-23
- Decision date
- 2013-01-25
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- MCW
- Device class
- 2
- Regulation number
- 870.4875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Colorado Springs, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 41 recall (Z-0680-2025) | Spectranetics Corporation | 2024-12-16 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ELCA Coronary Atherectomy Catheters (P910001/S124) | Spectranetics Corp. | 2026-02-06 |
| ELCA Coronary Atherectomy Catheters (P910001/S125) | Spectranetics Corp. | 2025-12-18 |
| AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S035) | Spectranetics Corp. | 2025-04-04 |
| AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S036) | Spectranetics Corp. | 2025-01-15 |
| Philips Laser System (P910001/S123) | Spectranetics Corp. | 2024-11-21 |
| ELCA Coronary Angioplasty Laser Sheaths, Philips Laser System (CVX/PLS) (P910001/S122) | Spectranetics Corp. | 2024-09-05 |
| AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S034) | Spectranetics Corp. | 2024-02-14 |
| Philips Laser System (P910001/S121) | Spectranetics Corp. | 2023-10-30 |