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)

MACROPORE CARDIO-WRAP (TS)

K-Number: K031785 · 2003-09-04

ApplicantMacropore Biosurgery, Inc.
Decision Date2003-09-04
Product CodeOMH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MACROPORE CARDIO-WRAP (TS) is the device name listed in this FDA 510(k) record. The listed applicant is Macropore Biosurgery, Inc.. It received FDA 510(k) clearance on 2003-09-04 under 510(k) number K031785. The device is classified under product code OMH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MACROPORE CARDIO-WRAP (TS)?

MACROPORE CARDIO-WRAP (TS) is a medical device that received FDA 510(k) clearance on 2003-09-04. The listed applicant is Macropore Biosurgery, Inc.. The 510(k) number is K031785.

When did MACROPORE CARDIO-WRAP (TS) receive FDA 510(k) clearance?

MACROPORE CARDIO-WRAP (TS) received FDA 510(k) clearance on 2003-09-04, under 510(k) number K031785.

Who is the listed applicant for MACROPORE CARDIO-WRAP (TS)?

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

What is the FDA product code for MACROPORE CARDIO-WRAP (TS)?

The FDA product code for MACROPORE CARDIO-WRAP (TS) is OMH.

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 Macropore Biosurgery, 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.

K042261MACROPORE PURICEL LIPOPLASTY SYSTEMK041105MACROPORE HYDROSORB SPINE SYSTEMK031955MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEETK024169MACROPORE OS RECONSTRUCTIONK023643MACROPORE SURGICAL BARRIER FILMK021164MACROPORE OS TRAUMA

View all 17 devices →

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.

↑