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FDA Product Code

FDA Product Code LIT — Clearance Directory

Device Class
Class II
Assigned Panel
Cardiovascular
21 CFR Citation
870.1250

510(k) Clearances — 405 records · page 5 of 5

K-Number Device Name Applicant Decision Date Clearance Type Summary
K830608 USCI GRUNTZIG DILACA BALLOON DILATION C.R. Bard, Inc. 1983-03-24 Traditional PDF ↗
K822245 INDEFLATOR Advanced Cardiovascular Systems, Inc. 1982-08-31 Traditional PDF ↗
K813331 P51 ANGIOPLASTY PRESSURE TRANSDUCER Konigsberg Instruments, Inc. 1981-12-29 Traditional PDF ↗
K812168 CORDIS DUCOR PERCUT. TRANS. ANGIO. CATH. Cordis Corp. 1981-08-31 Traditional PDF ↗
K803057 FOGARTY BALLON ANGIOPLASTY CATHETERS American Edwards Laboratories 1981-01-13 Traditional PDF ↗

Product code LIT · Class II · Cardiovascular. Data: openFDA.