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FDA 510(k)

DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS)

K-Number: K091760 · 2009-07-20

ApplicantDermaport, Inc.
Decision Date2009-07-20
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS) is the device name listed in this FDA 510(k) record. The listed applicant is Dermaport, Inc.. It received FDA 510(k) clearance on 2009-07-20 under 510(k) number K091760. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS)?

DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS) is a medical device that received FDA 510(k) clearance on 2009-07-20. The listed applicant is Dermaport, Inc.. The 510(k) number is K091760.

When did DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS) receive FDA 510(k) clearance?

DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS) received FDA 510(k) clearance on 2009-07-20, under 510(k) number K091760.

Who is the listed applicant for DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS)?

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

What is the FDA product code for DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS)?

The FDA product code for DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS) is MSD.

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 Dermaport, 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.

K071202DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS)

Related Devices (Code: MSD)

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.

K241581Hemodialysis CatheterHaolang Medical USA CorporationK210461End CapMedical Components Inc (Medcomp)K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc.K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc.K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc.K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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