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NLI

Catheter, Angiography, Reprocessed

Product code
NLI
Device name
Catheter, Angiography, Reprocessed
Device class
Class 2
21 CFR
21 CFR 870.1200
Medical specialty
Cardiovascular
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
1 (all years; only the last 3 years are listed here)

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-07-01.

NumberDecision dateApplicantDevice nameSummary
K2310152024-07-01Innovative Health, LLCReprocessed Super Torque and Super Torque Plus Diagn…PDF

1 summaries are archived here for direct download.

Official FDA classification page: NLI
Classification and pathway per current FDA publications. Data from openFDA (CC0).