FDA 510(k)

COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER

K-Number: K853651 · 1985-10-23

Decision Date1985-10-23

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER 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 1985-10-23 under 510(k) number K853651. 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 COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER?

COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER is a medical device that received FDA 510(k) clearance on 1985-10-23. The listed applicant is Cook Pacemaker Corp.. The 510(k) number is K853651.

When did COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER receive FDA 510(k) clearance?

COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER received FDA 510(k) clearance on 1985-10-23, under 510(k) number K853651.

Who is the listed applicant for COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER?

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 COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER?

The FDA product code for COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER is DXY. This falls under the Clinical Chemistry category.

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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

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