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FDA 510(k)

HALO360' COAGULATION CATHETER

K-Number: K071543 · 2007-06-29

ApplicantBarrx Medical, Incorporated
Decision Date2007-06-29
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HALO360' COAGULATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Barrx Medical, Incorporated. It received FDA 510(k) clearance on 2007-06-29 under 510(k) number K071543. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HALO360' COAGULATION CATHETER?

HALO360' COAGULATION CATHETER is a medical device that received FDA 510(k) clearance on 2007-06-29. The listed applicant is Barrx Medical, Incorporated. The 510(k) number is K071543.

When did HALO360' COAGULATION CATHETER receive FDA 510(k) clearance?

HALO360' COAGULATION CATHETER received FDA 510(k) clearance on 2007-06-29, under 510(k) number K071543.

Who is the listed applicant for HALO360' COAGULATION CATHETER?

The FDA 510(k) record lists Barrx Medical, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HALO360' COAGULATION CATHETER?

The FDA product code for HALO360' COAGULATION CATHETER is GEI.

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Other records listing Barrx Medical, Incorporated 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.

K093855HALO 360 & SIZING BALLOON, MODEL 3441CK093008HALO ABLATION CATHETER, MODEL 90-9100K092487HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230AK083737HALO ABLATION CATHETERK083711MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34K082202HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B

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Related Devices (Code: GEI)

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.

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL Co., 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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