Catheter, Angiography, Reprocessed
The Reprocessed Angiography Catheter is a reprocessed cardiovascular catheter used to deliver contrast media into blood vessels for angiographic imaging of the vasculature and cardiac structures; reprocessing validation data must be included in a 510(k) submission. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NLI and regulation 21 CFR 870.1200 in the Cardiovascular specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- NLI
- Device Class
- FDA class 2
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K231015 | Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters | Jul 01, 2024 | Substantially Equivalent | Innovative Health, LLC |