FDA product code NLI: Catheter, Angiography, Reprocessed
NLI is the FDA product code for catheter, angiography, reprocessed. It is a Class II device, regulated under 21 CFR 870.1200 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under NLI, 1 in the last five years. The average 510(k) review took 448 days (median 448); 448 days on average over the last three years. FDA has posted 1 recall for NLI devices.
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).
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Angiography, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 870.1200 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for NLI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 448 |
Compare with all 510(k) review times · Search every NLI clearance
Top NLI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Innovative Health, LLC | 1 | 2024-07-01 |
Most recent NLI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231015 | Innovative Health, LLC | Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters | 2024-07-01 | 448 |
Recalls for NLI devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-08-08.
Frequently asked questions
What is FDA product code NLI?
NLI is the FDA product code for catheter, angiography, reprocessed. It is a Class II device, regulated under 21 CFR 870.1200 and reviewed by the Cardiovascular panel.
What device class is NLI?
Class II, regulation 21 CFR 870.1200. Typical premarket route: 510(k).
How long does a 510(k) take for product code NLI?
Across 1 cleared submissions the average was 448 days from receipt to decision (median 448).
Which companies have the most NLI clearances?
Innovative Health, LLC (1).
Have NLI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-08-08.
Next steps
- Run an FDA pathway report with predicate devices for product code NLI
- Run a recall and safety report across every NLI manufacturer
- Watch product code NLI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times