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FDA 510(k)

OCCLUSION BALLON CATHETER MODIFICAION

K-Number: K921399 · 1992-09-25

ApplicantInterventional Therapeutics Corp.
Decision Date1992-09-25
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OCCLUSION BALLON CATHETER MODIFICAION is the device name listed in this FDA 510(k) record. The listed applicant is Interventional Therapeutics Corp.. It received FDA 510(k) clearance on 1992-09-25 under 510(k) number K921399. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCCLUSION BALLON CATHETER MODIFICAION?

OCCLUSION BALLON CATHETER MODIFICAION is a medical device that received FDA 510(k) clearance on 1992-09-25. The listed applicant is Interventional Therapeutics Corp.. The 510(k) number is K921399.

When did OCCLUSION BALLON CATHETER MODIFICAION receive FDA 510(k) clearance?

OCCLUSION BALLON CATHETER MODIFICAION received FDA 510(k) clearance on 1992-09-25, under 510(k) number K921399.

Who is the listed applicant for OCCLUSION BALLON CATHETER MODIFICAION?

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

What is the FDA product code for OCCLUSION BALLON CATHETER MODIFICAION?

The FDA product code for OCCLUSION BALLON CATHETER MODIFICAION is DXC.

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Other records listing Interventional Therapeutics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K960832OCCLUSION BALLOON CATHETERK950398CATHETER, BALLOON TYPEK945588DISPOSABLE 1CC SYRINGE WITH LUER LOCKK944354CONTOUR EMBOLIK930456INTHERM SINGLE-STICK RADIALLY EXPANDING DILATORK914866ITC CONTOUR EMBOLI, MODIFICATION

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Related Devices (Code: DXC)

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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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