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FDA 510(k)

DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)

K-Number: K000704 · 2000-05-19

ApplicantDmc Medical, Ltd.
Decision Date2000-05-19
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) is the device name listed in this FDA 510(k) record. The listed applicant is Dmc Medical, Ltd.. It received FDA 510(k) clearance on 2000-05-19 under 510(k) number K000704. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)?

DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) is a medical device that received FDA 510(k) clearance on 2000-05-19. The listed applicant is Dmc Medical, Ltd.. The 510(k) number is K000704.

When did DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) receive FDA 510(k) clearance?

DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) received FDA 510(k) clearance on 2000-05-19, under 510(k) number K000704.

Who is the listed applicant for DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)?

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

What is the FDA product code for DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)?

The FDA product code for DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) is GBX.

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 Dmc Medical, Ltd. 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.

K103736DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGEK992932CIPA (ADULTS) CIPI (INFANTS)

Related Devices (Code: GBX)

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.

K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLCK052286DEUTSCH ANTI-BLOCKAGE WOUND DRAINThe Catheter Exchange, Inc.K043515GRAFTSAVERVescare, Inc.K013417MISONIX IRRIGATION SYSTEM MOEDL BC20PMisonix, Inc.K974233LYSONIX IRRIGATION SYSTEMLysonix, Inc.K973703JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAINAllegiance Healthcare Corp.

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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