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FDA 510(k)

SOFTTOUCH GUIDE CATHETER

K-Number: K934685 · 1994-04-07

ApplicantMallinckrodt Medical
Decision Date1994-04-07
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOFTTOUCH GUIDE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Medical. It received FDA 510(k) clearance on 1994-04-07 under 510(k) number K934685. 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 SOFTTOUCH GUIDE CATHETER?

SOFTTOUCH GUIDE CATHETER is a medical device that received FDA 510(k) clearance on 1994-04-07. The listed applicant is Mallinckrodt Medical. The 510(k) number is K934685.

When did SOFTTOUCH GUIDE CATHETER receive FDA 510(k) clearance?

SOFTTOUCH GUIDE CATHETER received FDA 510(k) clearance on 1994-04-07, under 510(k) number K934685.

Who is the listed applicant for SOFTTOUCH GUIDE CATHETER?

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

What is the FDA product code for SOFTTOUCH GUIDE CATHETER?

The FDA product code for SOFTTOUCH GUIDE CATHETER is DQY.

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Other records listing Mallinckrodt Medical 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.

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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.

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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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