NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
FDA 510(k) clearance K220171 · decided 2022-07-01
Clearance details
- K-number
- K220171
- Device name
- NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
- Applicant
- Northeast Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-01-21
- Decision date
- 2022-07-01
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- QTF
- Device class
- 2
- Regulation number
- 870.4875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Waterbury, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. recall (Z-0018-2026) | Northeast Scientific Inc. | 2025-10-02 |