FDA 510(k)

COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM

K-Number: K850656 · 1985-03-01

Decision Date1985-03-01

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM 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 1985-03-01 under 510(k) number K850656. 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 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM?

COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM is a medical device that received FDA 510(k) clearance on 1985-03-01. The listed applicant is Cook Pacemaker Corp.. The 510(k) number is K850656.

When did COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM receive FDA 510(k) clearance?

COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM received FDA 510(k) clearance on 1985-03-01, under 510(k) number K850656.

Who is the listed applicant for COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM?

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 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM?

The FDA product code for COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM is DXY. This falls under the Clinical Chemistry category.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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)

View all 34 devices →

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.