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FDA 510(k)

SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP

K-Number: K912191 · 1991-07-30

ApplicantMallinckrodt Medical
Decision Date1991-07-30
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Medical. It received FDA 510(k) clearance on 1991-07-30 under 510(k) number K912191. 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 SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP?

SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP is a medical device that received FDA 510(k) clearance on 1991-07-30. The listed applicant is Mallinckrodt Medical. The 510(k) number is K912191.

When did SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP receive FDA 510(k) clearance?

SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP received FDA 510(k) clearance on 1991-07-30, under 510(k) number K912191.

Who is the listed applicant for SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP?

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 SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP?

The FDA product code for SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP is DQY.

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Other records listing Mallinckrodt Medical as applicant

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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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