NLI — Catheter, Angiography, Reprocessed Class II
Classification Details
- Product Code
- NLI
- Device Class
- Class II
- Regulation Number
- 870.1200
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K231015 | innovative health | Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters | July 1, 2024 |