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)

ATRIUM'S HYBRID PTFE

K-Number: K933391 · 1994-12-15

ApplicantAtrium Medical Corp.
Decision Date1994-12-15
Product CodeDYF
Advisory CommitteeCV
DecisionUnknown

Device Summary

ATRIUM'S HYBRID PTFE is the device name listed in this FDA 510(k) record. The listed applicant is Atrium Medical Corp.. It received FDA 510(k) clearance on 1994-12-15 under 510(k) number K933391. The device is classified under product code DYF. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ATRIUM'S HYBRID PTFE?

ATRIUM'S HYBRID PTFE is a medical device that received FDA 510(k) clearance on 1994-12-15. The listed applicant is Atrium Medical Corp.. The 510(k) number is K933391.

When did ATRIUM'S HYBRID PTFE receive FDA 510(k) clearance?

ATRIUM'S HYBRID PTFE received FDA 510(k) clearance on 1994-12-15, under 510(k) number K933391.

Who is the listed applicant for ATRIUM'S HYBRID PTFE?

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

What is the FDA product code for ATRIUM'S HYBRID PTFE?

The FDA product code for ATRIUM'S HYBRID PTFE is DYF.

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 Atrium Medical Corp. 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.

K130131EDRAIN CHEST DRAINAGE SYSTEMK122138ATRIUM FLIXENE IFG VASCULAR GRAFTK121070C-QUR RPM MESHK113112CLEARWAY RX NB CATHETERK102596ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFTK093431CLEARWAY OTW MODEL 85912

View all 63 devices →

Related Devices (Code: DYF)

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.

K004012IMPRA CARBOFLO EPTFE VASCULAR GRAFTSImpra, Inc.K000504ADVANTA SUPER SOFT GRAFTAtrium Medical Corp.K992958ADVANTA GRAFT (<6MM)Atrium Medical Corp.K991683PTFE RINGED GORE-TEX VASCULAR GRAFTW. L. Gore & Associates, Inc.K992441ADVANTA GRAFTAtrium Medical Corp.K984183PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451Possis Medical, 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.

↑