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FDA 510(k)

VIEWCATH 3-D CATHETER PULLBACK

K-Number: K971397 · 1997-08-25

ApplicantQuinton, Inc.
Decision Date1997-08-25
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VIEWCATH 3-D CATHETER PULLBACK is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1997-08-25 under 510(k) number K971397. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIEWCATH 3-D CATHETER PULLBACK?

VIEWCATH 3-D CATHETER PULLBACK is a medical device that received FDA 510(k) clearance on 1997-08-25. The listed applicant is Quinton, Inc.. The 510(k) number is K971397.

When did VIEWCATH 3-D CATHETER PULLBACK receive FDA 510(k) clearance?

VIEWCATH 3-D CATHETER PULLBACK received FDA 510(k) clearance on 1997-08-25, under 510(k) number K971397.

Who is the listed applicant for VIEWCATH 3-D CATHETER PULLBACK?

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

What is the FDA product code for VIEWCATH 3-D CATHETER PULLBACK?

The FDA product code for VIEWCATH 3-D CATHETER PULLBACK is ITX.

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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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