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FDA 510(k)

CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL

K-Number: K811539 · 1981-07-01

ApplicantCordis Corp.
Decision Date1981-07-01
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1981-07-01 under 510(k) number K811539. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL?

CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL is a medical device that received FDA 510(k) clearance on 1981-07-01. The listed applicant is Cordis Corp.. The 510(k) number is K811539.

When did CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL receive FDA 510(k) clearance?

CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL received FDA 510(k) clearance on 1981-07-01, under 510(k) number K811539.

Who is the listed applicant for CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL?

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 CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL?

The FDA product code for CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL is DTB.

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Other records listing Cordis Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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: DTB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic VascularK031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, Inc.

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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