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FDA 510(k)

CATHETER, BALLOON TYPE

K-Number: K950398 · 1995-10-05

ApplicantInterventional Therapeutics Corp.
Decision Date1995-10-05
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CATHETER, BALLOON TYPE 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 1995-10-05 under 510(k) number K950398. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER, BALLOON TYPE?

CATHETER, BALLOON TYPE is a medical device that received FDA 510(k) clearance on 1995-10-05. The listed applicant is Interventional Therapeutics Corp.. The 510(k) number is K950398.

When did CATHETER, BALLOON TYPE receive FDA 510(k) clearance?

CATHETER, BALLOON TYPE received FDA 510(k) clearance on 1995-10-05, under 510(k) number K950398.

Who is the listed applicant for CATHETER, BALLOON TYPE?

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 CATHETER, BALLOON TYPE?

The FDA product code for CATHETER, BALLOON TYPE is DQO.

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Other records listing Interventional Therapeutics Corp. as applicant

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Related Devices (Code: DQO)

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K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

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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