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FDA 510(k)

ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002

K-Number: K033424 · 2003-12-11

ApplicantTransonic Systems, Inc.
Decision Date2003-12-11
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 is the device name listed in this FDA 510(k) record. The listed applicant is Transonic Systems, Inc.. It received FDA 510(k) clearance on 2003-12-11 under 510(k) number K033424. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002?

ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 is a medical device that received FDA 510(k) clearance on 2003-12-11. The listed applicant is Transonic Systems, Inc.. The 510(k) number is K033424.

When did ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 receive FDA 510(k) clearance?

ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 received FDA 510(k) clearance on 2003-12-11, under 510(k) number K033424.

Who is the listed applicant for ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002?

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

What is the FDA product code for ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002?

The FDA product code for ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 is DPW.

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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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