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)

HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO

K-Number: K873771 · 1987-12-18

ApplicantAmerican V. Mueller
Decision Date1987-12-18
Product CodeGYK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO is the device name listed in this FDA 510(k) record. The listed applicant is American V. Mueller. It received FDA 510(k) clearance on 1987-12-18 under 510(k) number K873771. The device is classified under product code GYK. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO?

HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO is a medical device that received FDA 510(k) clearance on 1987-12-18. The listed applicant is American V. Mueller. The 510(k) number is K873771.

When did HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO receive FDA 510(k) clearance?

HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO received FDA 510(k) clearance on 1987-12-18, under 510(k) number K873771.

Who is the listed applicant for HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO?

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

What is the FDA product code for HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO?

The FDA product code for HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO is GYK.

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 American V. Mueller 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.

K873332MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEMK871685HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYSK864676HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEMK862772V. MUELLER (R) GOOSENECK CIRCULAR STAPLERK861471V. MUELLER VITAL CLIP-HEMOSTATIC CLIPK854568V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP

View all 31 devices →

Related Devices (Code: GYK)

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.

K962761REIGEL TUNNELING DEVICECook, Inc.K934391V/P AND L/P CATHETER PASSERSRadionics, Inc.K930606PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSERPudenz-Schulte Medical Research Corp.K932273CORDIS TUNNELERCordis Corp.K895868HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSEBaxter Healthcare CorpK883607PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETERCodman & Shurtleff, 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.

↑