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FDA 510(k)

MODEL 325C UNIPOLAR CARDIAC PULSE GEN.

K-Number: K812832 · 1981-11-05

ApplicantCook Pacemaker Corp.
Decision Date1981-11-05
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 325C UNIPOLAR CARDIAC PULSE GEN. is the device name listed in this FDA 510(k) record. The listed applicant is Cook Pacemaker Corp.. It received FDA 510(k) clearance on 1981-11-05 under 510(k) number K812832. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 325C UNIPOLAR CARDIAC PULSE GEN.?

MODEL 325C UNIPOLAR CARDIAC PULSE GEN. is a medical device that received FDA 510(k) clearance on 1981-11-05. The listed applicant is Cook Pacemaker Corp.. The 510(k) number is K812832.

When did MODEL 325C UNIPOLAR CARDIAC PULSE GEN. receive FDA 510(k) clearance?

MODEL 325C UNIPOLAR CARDIAC PULSE GEN. received FDA 510(k) clearance on 1981-11-05, under 510(k) number K812832.

Who is the listed applicant for MODEL 325C UNIPOLAR CARDIAC PULSE GEN.?

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

What is the FDA product code for MODEL 325C UNIPOLAR CARDIAC PULSE GEN.?

The FDA product code for MODEL 325C UNIPOLAR CARDIAC PULSE GEN. is DXY. This falls under the Clinical Chemistry category.

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Other records listing Cook Pacemaker 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.

K970690LOCKING STYLET 2K961992NEEDLE'S EYE SNAREK953417MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORSK915188MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEADK905403MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMERK863582MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)

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Related Devices (Code: DXY)

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.

K993434PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-ABiotronik, Inc.K970072OPUS S MODEL 4121 AND 4124 PACEMAKERSEla Medical, Inc.K945627PIKOS LP 01, PIKOS LP E01Biotronik, Inc.K953866MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)Medtronic VascularK954092ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)Medtronic VascularK953417MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORSCook Pacemaker Corp.

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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