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)

ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET

K-Number: K925533 · 1993-01-12

ApplicantAngeion Corp.
Decision Date1993-01-12
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET is the device name listed in this FDA 510(k) record. The listed applicant is Angeion Corp.. It received FDA 510(k) clearance on 1993-01-12 under 510(k) number K925533. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET?

ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET is a medical device that received FDA 510(k) clearance on 1993-01-12. The listed applicant is Angeion Corp.. The 510(k) number is K925533.

When did ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET receive FDA 510(k) clearance?

ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET received FDA 510(k) clearance on 1993-01-12, under 510(k) number K925533.

Who is the listed applicant for ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET?

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

What is the FDA product code for ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET?

The FDA product code for ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET is GBX.

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 Angeion 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.

K921757ANGEION IGITAL ANGEFLATORK915719ANGEION ENDOSCOPIC VALVE SEALK902377ANGEFLATOR(TM)K895580Y-ADAPTER W/THOUY BORSTK894446ANGEION HEMOSTASIS VALVE INTRODUCERK871153CATHETER INTRODUCER

View all 7 devices →

Related Devices (Code: GBX)

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.

K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLCK052286DEUTSCH ANTI-BLOCKAGE WOUND DRAINThe Catheter Exchange, Inc.K043515GRAFTSAVERVescare, Inc.K013417MISONIX IRRIGATION SYSTEM MOEDL BC20PMisonix, Inc.K000704DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.K974233LYSONIX IRRIGATION SYSTEMLysonix, 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.

↑