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FDA product code NKR

System, Catheter Control, Reprocessed

Cardiovascular·Class 2·21 CFR 870.1290
US regulatory classifications
US Product Code (FDA)
NKR
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.1290
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Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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).

Search keywords

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01Catheter control02Reprocessed catheter03Catheter system04Control system05Medical control06Reprocessed device07Cath control08Steerable catheter09Catheter accessory10Cath system
About this record

System, Catheter Control, Reprocessed is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.