TORQMAX SHEATH GRIP ACCESSORY
FDA 510(k) clearance K093257 · decided 2010-03-26
Clearance details
- K-number
- K093257
- Device name
- TORQMAX SHEATH GRIP ACCESSORY
- Applicant
- Spectranetics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2009-10-19
- Decision date
- 2010-03-26
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- OFC
- Device class
- 2
- Regulation number
- 870.1340
- 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
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |
| AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S033) | Spectranetics Corp. | 2023-10-19 |