FDA 510(k)

MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.

K-Number: K860466 · 1986-02-24

Decision Date1986-02-24

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. 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 1986-02-24 under 510(k) number K860466. 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 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.?

MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN. is a medical device that received FDA 510(k) clearance on 1986-02-24. The listed applicant is Cook Pacemaker Corp.. The 510(k) number is K860466.

When did MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN. receive FDA 510(k) clearance?

MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN. received FDA 510(k) clearance on 1986-02-24, under 510(k) number K860466.

Who is the listed applicant for MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. 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 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.?

The FDA product code for MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN. is DXY. This falls under the Clinical Chemistry category.

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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.

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Other records listing Cook Pacemaker Corp. as applicant

K970690LOCKING STYLET 2 K961992NEEDLE'S EYE SNARE K953417MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS K915188MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD K905403MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER K863582MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)

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Related Devices (Code: DXY)

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 Vascular K954092ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)Medtronic Vascular K953417MINIFLEX 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.