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FDA 510(k)

MEDI-DYNE GUIDING CATHETER

K-Number: K970401 · 1997-08-01

ApplicantMedi-Dyne, Inc.
Decision Date1997-08-01
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDI-DYNE GUIDING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Dyne, Inc.. It received FDA 510(k) clearance on 1997-08-01 under 510(k) number K970401. 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 MEDI-DYNE GUIDING CATHETER?

MEDI-DYNE GUIDING CATHETER is a medical device that received FDA 510(k) clearance on 1997-08-01. The listed applicant is Medi-Dyne, Inc.. The 510(k) number is K970401.

When did MEDI-DYNE GUIDING CATHETER receive FDA 510(k) clearance?

MEDI-DYNE GUIDING CATHETER received FDA 510(k) clearance on 1997-08-01, under 510(k) number K970401.

Who is the listed applicant for MEDI-DYNE GUIDING CATHETER?

The FDA 510(k) record lists Medi-Dyne, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDI-DYNE GUIDING CATHETER?

The FDA product code for MEDI-DYNE GUIDING CATHETER is DQY.

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Other records listing Medi-Dyne, Inc. 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.

K0008254F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETERK931833MODIFIED LUERK930694MEDI-DYNE ANGIOGRAPHIC CATHETER

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

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

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