Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FIBRI-FILTER 20

K-Number: K813001 · 1981-11-06

ApplicantTri-Med, Inc.
Decision Date1981-11-06
Product CodeFPB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FIBRI-FILTER 20 is the device name listed in this FDA 510(k) record. The listed applicant is Tri-Med, Inc.. It received FDA 510(k) clearance on 1981-11-06 under 510(k) number K813001. The device is classified under product code FPB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBRI-FILTER 20?

FIBRI-FILTER 20 is a medical device that received FDA 510(k) clearance on 1981-11-06. The listed applicant is Tri-Med, Inc.. The 510(k) number is K813001.

When did FIBRI-FILTER 20 receive FDA 510(k) clearance?

FIBRI-FILTER 20 received FDA 510(k) clearance on 1981-11-06, under 510(k) number K813001.

Who is the listed applicant for FIBRI-FILTER 20?

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

What is the FDA product code for FIBRI-FILTER 20?

The FDA product code for FIBRI-FILTER 20 is FPB.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tri-Med, 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.

K040112TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATEK030877TRIMED RADIAL BULLETK010545TBWK961863PARACENTESIS TRAYSK875224HUDSON CRANINAL BURRSK850747TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR

View all 29 devices →

Related Devices (Code: FPB)

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.

K261403Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion FilterGlobal Life Sciences Solutions USA, LLCK233277Filter Needle for Single UseHangzhou Qiantang Longyue Biotechnology Co., Ltd.K113227NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTERBaxter Healthcare CorpK021293ARTERIA BLOOD FILTERArteria Medical Science, Inc.K993379PALL SUPOR AEF FILTERPall Corp.K9746610.2 U BACTERIAL FILTERSims Deltec, 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.

↑