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)

BYPASS COIL

K-Number: K811068 · 1981-05-27

ApplicantG.D. Searle and Co.
Decision Date1981-05-27
Product CodeKPY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BYPASS COIL is the device name listed in this FDA 510(k) record. The listed applicant is G.D. Searle and Co.. It received FDA 510(k) clearance on 1981-05-27 under 510(k) number K811068. The device is classified under product code KPY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BYPASS COIL?

BYPASS COIL is a medical device that received FDA 510(k) clearance on 1981-05-27. The listed applicant is G.D. Searle and Co.. The 510(k) number is K811068.

When did BYPASS COIL receive FDA 510(k) clearance?

BYPASS COIL received FDA 510(k) clearance on 1981-05-27, under 510(k) number K811068.

Who is the listed applicant for BYPASS COIL?

The FDA 510(k) record lists G.D. Searle and Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BYPASS COIL?

The FDA product code for BYPASS COIL is KPY.

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 G.D. Searle and Co. 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.

K821159IN-LINE OXYGEN MONITORING SYSTEMK811071VENOUS OXYGEN PROBEK803238INTRAVASCULAR CATHETERK810630SILICONE ELASTOMER COATED LATEX FOLEYK810131ADMINISTRATION SETK802485SEARLE VASCULAR LOOPS

View all 56 devices →

Related Devices (Code: KPY)

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.

K110900DISPOSABLE THYROID COLLARBloxr CorporationK962622INTRA-ORAL THERMOPLASTIC SHIELDMedtec, Inc.K954456THERMOPLASTIC SHIELDMedtec, Inc.K954146UTK-DTE AUTILARY SHIELDMallinckrodt MedicalK953610AUKULYTEAukland Medical Plastics, Inc.K9510042001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)Kenex , Ltd.

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.

↑