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FDA 510(k)

STANICOR, OMNI-STAN,MOD 333B,334A GAMMA

K-Number: K792348 · 1979-12-05

ApplicantCordis Corp.
Decision Date1979-12-05
Product CodeDTX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STANICOR, OMNI-STAN,MOD 333B,334A GAMMA is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1979-12-05 under 510(k) number K792348. The device is classified under product code DTX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STANICOR, OMNI-STAN,MOD 333B,334A GAMMA?

STANICOR, OMNI-STAN,MOD 333B,334A GAMMA is a medical device that received FDA 510(k) clearance on 1979-12-05. The listed applicant is Cordis Corp.. The 510(k) number is K792348.

When did STANICOR, OMNI-STAN,MOD 333B,334A GAMMA receive FDA 510(k) clearance?

STANICOR, OMNI-STAN,MOD 333B,334A GAMMA received FDA 510(k) clearance on 1979-12-05, under 510(k) number K792348.

Who is the listed applicant for STANICOR, OMNI-STAN,MOD 333B,334A GAMMA?

The FDA 510(k) record lists Cordis Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STANICOR, OMNI-STAN,MOD 333B,334A GAMMA?

The FDA product code for STANICOR, OMNI-STAN,MOD 333B,334A GAMMA is DTX.

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Other records listing Cordis Corp. as applicant

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K112797POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERK101651ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIREK082143MICRO GUIDE CATHETER XPK062798SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MBK060877PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAXK050645CORDIS AMIIA .014 PTA BALLOON CATHETER

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Related Devices (Code: DTX)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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