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FDA 510(k)

FOCUS BALLOON DILATATION CATHETER

K-Number: K944016 · 1994-12-20

ApplicantCardiovascular Dynamics, Inc.
Decision Date1994-12-20
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FOCUS BALLOON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Dynamics, Inc.. It received FDA 510(k) clearance on 1994-12-20 under 510(k) number K944016. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOCUS BALLOON DILATATION CATHETER?

FOCUS BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 1994-12-20. The listed applicant is Cardiovascular Dynamics, Inc.. The 510(k) number is K944016.

When did FOCUS BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

FOCUS BALLOON DILATATION CATHETER received FDA 510(k) clearance on 1994-12-20, under 510(k) number K944016.

Who is the listed applicant for FOCUS BALLOON DILATATION CATHETER?

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

What is the FDA product code for FOCUS BALLOON DILATATION CATHETER?

The FDA product code for FOCUS BALLOON DILATATION CATHETER is LIT.

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Other records listing Cardiovascular Dynamics, Inc. 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.

K97371322 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CARK971577FOCUS-PV BALLOON DILATATION CATHETERK963989P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICEK963688FOCUS PV BALLOON DILATATION CATHETERK945693CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETERK952064FOCUS BALLOON DILATATION CATHETER

View all 11 devices →

Related Devices (Code: LIT)

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.

K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, Inc.

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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