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FDA 510(k)

MEDTRONIC ZUMA GUIDING CATHETER

K-Number: K981198 · 1998-08-07

ApplicantMedtronics Interventional Vascular
Decision Date1998-08-07
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDTRONIC ZUMA GUIDING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medtronics Interventional Vascular. It received FDA 510(k) clearance on 1998-08-07 under 510(k) number K981198. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDTRONIC ZUMA GUIDING CATHETER?

MEDTRONIC ZUMA GUIDING CATHETER is a medical device that received FDA 510(k) clearance on 1998-08-07. The listed applicant is Medtronics Interventional Vascular. The 510(k) number is K981198.

When did MEDTRONIC ZUMA GUIDING CATHETER receive FDA 510(k) clearance?

MEDTRONIC ZUMA GUIDING CATHETER received FDA 510(k) clearance on 1998-08-07, under 510(k) number K981198.

Who is the listed applicant for MEDTRONIC ZUMA GUIDING CATHETER?

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

What is the FDA product code for MEDTRONIC ZUMA GUIDING CATHETER?

The FDA product code for MEDTRONIC ZUMA GUIDING CATHETER is DQY.

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Other records listing Medtronics Interventional Vascular as applicant

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.

K990707MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERSK980973MEDTRONIC ANGIOGRAPHIC CATHETERK982883MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETERK972944MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORTK961917MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX)K960983MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT

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Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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.

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