FDA 510(k)

IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR

K-Number: K894040 · 1989-07-14

Decision Date1989-07-14

Product CodeDTB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1989-07-14 under 510(k) number K894040. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR?

IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Medtronic Vascular. The 510(k) number is K894040.

When did IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR receive FDA 510(k) clearance?

IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR received FDA 510(k) clearance on 1989-07-14, under 510(k) number K894040.

Who is the listed applicant for IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR?

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

What is the FDA product code for IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR?

The FDA product code for IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR is DTB.

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 Medtronic Vascular as applicant

K232570Steerant™ Super Stiff Guidewire K2321906F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter K2301565F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter K220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)K192296Medtronic 6F Taiga Guiding Catheter K173515Admiral Xtreme

View all 474 devices →

Related Devices (Code: DTB)

K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic Vascular K031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, 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.