FDA 510(k)

SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT

K-Number: K030984 · 2003-04-24

ApplicantIntra Luminal Therapeutics, Inc.

Decision Date2003-04-24

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT is the device name listed in this FDA 510(k) record. The listed applicant is Intra Luminal Therapeutics, Inc.. It received FDA 510(k) clearance on 2003-04-24 under 510(k) number K030984. 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 SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT?

SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT is a medical device that received FDA 510(k) clearance on 2003-04-24. The listed applicant is Intra Luminal Therapeutics, Inc.. The 510(k) number is K030984.

When did SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT receive FDA 510(k) clearance?

SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT received FDA 510(k) clearance on 2003-04-24, under 510(k) number K030984.

Who is the listed applicant for SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT?

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

What is the FDA product code for SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT?

The FDA product code for SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT is DQY.

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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.