NLI
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Catheter, Angiography, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Medical specialty
- Cardiovascular
- FDA definition
- Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
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| Record | Firm | Date |
|---|---|---|
| Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters (K231015) | Innovative Health, LLC | 2024-07-01 |
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Every clearance here is in the API, with alerts when new ones post.