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)

PORTAPULSE

K-Number: K812131 · 1981-09-21

ApplicantGavon, Inc.
Decision Date1981-09-21
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PORTAPULSE is the device name listed in this FDA 510(k) record. The listed applicant is Gavon, Inc.. It received FDA 510(k) clearance on 1981-09-21 under 510(k) number K812131. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTAPULSE?

PORTAPULSE is a medical device that received FDA 510(k) clearance on 1981-09-21. The listed applicant is Gavon, Inc.. The 510(k) number is K812131.

When did PORTAPULSE receive FDA 510(k) clearance?

PORTAPULSE received FDA 510(k) clearance on 1981-09-21, under 510(k) number K812131.

Who is the listed applicant for PORTAPULSE?

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

What is the FDA product code for PORTAPULSE?

The FDA product code for PORTAPULSE is DRT.

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

Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

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.

↑