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FDA 510(k)

ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F

K-Number: K111252 · 2011-06-02

ApplicantBoston Scientific Corp
Decision Date2011-06-02
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2011-06-02 under 510(k) number K111252. 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 ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F?

ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F is a medical device that received FDA 510(k) clearance on 2011-06-02. The listed applicant is Boston Scientific Corp. The 510(k) number is K111252.

When did ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F receive FDA 510(k) clearance?

ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F received FDA 510(k) clearance on 2011-06-02, under 510(k) number K111252.

Who is the listed applicant for ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F?

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

What is the FDA product code for ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F?

The FDA product code for ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F is DQY.

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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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