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FDA 510(k)

PTCA BALLOON CATHETERS & ACCESSORIES

K-Number: K843944 · 1985-02-14

ApplicantAdvanced Cardiovascular Systems, Inc.
Decision Date1985-02-14
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PTCA BALLOON CATHETERS & ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 1985-02-14 under 510(k) number K843944. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTCA BALLOON CATHETERS & ACCESSORIES?

PTCA BALLOON CATHETERS & ACCESSORIES is a medical device that received FDA 510(k) clearance on 1985-02-14. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K843944.

When did PTCA BALLOON CATHETERS & ACCESSORIES receive FDA 510(k) clearance?

PTCA BALLOON CATHETERS & ACCESSORIES received FDA 510(k) clearance on 1985-02-14, under 510(k) number K843944.

Who is the listed applicant for PTCA BALLOON CATHETERS & ACCESSORIES?

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

What is the FDA product code for PTCA BALLOON CATHETERS & ACCESSORIES?

The FDA product code for PTCA BALLOON CATHETERS & ACCESSORIES is LOX.

Related Clinical Trials

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.

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Other records listing Advanced Cardiovascular Systems, 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.

K012534HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATINGK000550OTW MEGALINK SDS BILIARY STENT SYSTEMK994229VERIPATH PERIPHERAL GUIDING CATHETERK992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIREK990867RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18K963702ACS HI-TORQUE IRON MAN GUIDE WIRE

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Related Devices (Code: LOX)

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.

K261428NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic IrelandK261759Euphora Rapid Exchange (RX) Balloon Dilatation CatheterMedtronic IrelandK252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc.K252295RyureiTerumo CorporationK251970Sprinter Legend Rapid Exchange Balloon Dilatation CatheterMedtronic, Ireland

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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