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)

8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM

K-Number: K880777 · 1988-05-24

ApplicantMedsurg Industries, Inc.
Decision Date1988-05-24
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medsurg Industries, Inc.. It received FDA 510(k) clearance on 1988-05-24 under 510(k) number K880777. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM?

8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM is a medical device that received FDA 510(k) clearance on 1988-05-24. The listed applicant is Medsurg Industries, Inc.. The 510(k) number is K880777.

When did 8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM receive FDA 510(k) clearance?

8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM received FDA 510(k) clearance on 1988-05-24, under 510(k) number K880777.

Who is the listed applicant for 8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM?

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

What is the FDA product code for 8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM?

The FDA product code for 8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM is DWF.

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 Medsurg Industries, 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.

K920780MEDSURG INSERTION TRAYK940175MEDSURG STERILE O.R. TOWELSK934731MEDSURG STERILE IMAGING PRODUCTSK925558INFILTUBEK934971STERILE LAPAROTOMY SPONGESK920421MEDSURG MARSHMALLOW TRAY

View all 41 devices →

Related Devices (Code: DWF)

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.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, 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.

↑