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)

SHEATH DILATOR SET

K-Number: K802327 · 1980-10-10

ApplicantStanco Medical, Inc.
Decision Date1980-10-10
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SHEATH DILATOR SET is the device name listed in this FDA 510(k) record. The listed applicant is Stanco Medical, Inc.. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K802327. 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 SHEATH DILATOR SET?

SHEATH DILATOR SET is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Stanco Medical, Inc.. The 510(k) number is K802327.

When did SHEATH DILATOR SET receive FDA 510(k) clearance?

SHEATH DILATOR SET received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802327.

Who is the listed applicant for SHEATH DILATOR SET?

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

What is the FDA product code for SHEATH DILATOR SET?

The FDA product code for SHEATH DILATOR SET 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 Stanco Medical, 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.

K810642ATRIAL-VENTRICULAR PACING ELECTRODE KITK810643UNIVERSAL PACING ELECTRODE KITK802289PERICARDIOCENTESIS KITK802287RIGHT ATRIAL LINE KITK802288SWAN GANZ CATHETER PLACEMENT KITK802259TRANSVENOUS PACEMAKER ELECTRODE KIT

View all 19 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.

↑