FDA Product Code NLI: Catheter, Angiography, Reprocessed
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).
Leading manufacturers include Innovative Health, LLC.
FDA 510(k) Cleared Catheter, Angiography, Reprocessed Devices (Product Code NLI)
About Product Code NLI - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code NLI since 2024, with 1 receiving FDA clearance (average review time: 448 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
NLI devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →