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)

FLEXIBLE DILATING SHEATH

K-Number: K945586 · 1997-04-04

ApplicantMed Institute, Inc.
Decision Date1997-04-04
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE DILATING SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Med Institute, Inc.. It received FDA 510(k) clearance on 1997-04-04 under 510(k) number K945586. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXIBLE DILATING SHEATH?

FLEXIBLE DILATING SHEATH is a medical device that received FDA 510(k) clearance on 1997-04-04. The listed applicant is Med Institute, Inc.. The 510(k) number is K945586.

When did FLEXIBLE DILATING SHEATH receive FDA 510(k) clearance?

FLEXIBLE DILATING SHEATH received FDA 510(k) clearance on 1997-04-04, under 510(k) number K945586.

Who is the listed applicant for FLEXIBLE DILATING SHEATH?

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

What is the FDA product code for FLEXIBLE DILATING SHEATH?

The FDA product code for FLEXIBLE DILATING SHEATH is DRE.

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 Med Institute, 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.

K990034WILSON-COOK COLONIC Z-STENTK982507MINI POLYURETHANE CATHETERK981061INTRAVASCULAR RETRIEVAL DEVICEK964001SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEMK971140VITAL-PORT INFUSION PALK970442TARGET VITAL-PORT VASCULAR ACCESS SYSTEM

View all 26 devices →

Related Devices (Code: DRE)

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, 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.

↑