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FDA 510(k)

FLO-THRU

K-Number: K981624 · 1998-08-04

ApplicantBio-Vascular, Inc.
Decision Date1998-08-04
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLO-THRU is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Vascular, Inc.. It received FDA 510(k) clearance on 1998-08-04 under 510(k) number K981624. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLO-THRU?

FLO-THRU is a medical device that received FDA 510(k) clearance on 1998-08-04. The listed applicant is Bio-Vascular, Inc.. The 510(k) number is K981624.

When did FLO-THRU receive FDA 510(k) clearance?

FLO-THRU received FDA 510(k) clearance on 1998-08-04, under 510(k) number K981624.

Who is the listed applicant for FLO-THRU?

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

What is the FDA product code for FLO-THRU?

The FDA product code for FLO-THRU is DXC.

Other records listing Bio-Vascular, 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.

K002233BVI SLINGK992537PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATEDK983602CV PERI-GUARD AND VASCU-GUARDK983581OCU-GUARD AND OCU-GUARD SUPPLEK983162PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASCK982282DURA-GUARD - DURAL REPAIR PATCH

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Related Devices (Code: DXC)

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.

K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards LifesciencesK252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060Life Saving TourniquetTW MedicalK243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLCK253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP

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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