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FDA 510(k)

CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER)

K-Number: K844969 · 1985-05-01

ApplicantCordis Corp.
Decision Date1985-05-01
Product CodeDTC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER) is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1985-05-01 under 510(k) number K844969. The device is classified under product code DTC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER)?

CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER) is a medical device that received FDA 510(k) clearance on 1985-05-01. The listed applicant is Cordis Corp.. The 510(k) number is K844969.

When did CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER) receive FDA 510(k) clearance?

CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER) received FDA 510(k) clearance on 1985-05-01, under 510(k) number K844969.

Who is the listed applicant for CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER)?

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 DUAL-CHAMBER PSA MODEL 296A (PACEMAKER)?

The FDA product code for CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER) is DTC.

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Other records listing Cordis Corp. as applicant

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Related Devices (Code: DTC)

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.

K170815PSA CableBoston Scientific CorporationK083674PK-141 PATIENT CABLEBiotronik, Inc.K011729SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000Dni Nevada, Inc.K002497MODEL 4810 ANALYZER OUTPUT ADAPTERPace MedicalK961582EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100North American Technical Services Corp.K903966EXTERNAL PACEMAKER ANALYZER MODEL PMA-1Bio-Tek Instruments, 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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