FDA 510(k)

MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.

K-Number: K901535 · 1990-07-03

Decision Date1990-07-03

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE. is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1990-07-03 under 510(k) number K901535. 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 MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.?

MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE. is a medical device that received FDA 510(k) clearance on 1990-07-03. The listed applicant is Medtronic Vascular. The 510(k) number is K901535.

When did MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE. receive FDA 510(k) clearance?

MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE. received FDA 510(k) clearance on 1990-07-03, under 510(k) number K901535.

Who is the listed applicant for MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.?

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 MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.?

The FDA product code for MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE. 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 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: 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.