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 AFTERLOADING CATHETER

K-Number: K832738 · 1983-09-29

ApplicantAmerican Heyer Schulte
Decision Date1983-09-29
Product CodeIWJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HEYER-SCHULTE AFTERLOADING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is American Heyer Schulte. It received FDA 510(k) clearance on 1983-09-29 under 510(k) number K832738. The device is classified under product code IWJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEYER-SCHULTE AFTERLOADING CATHETER?

HEYER-SCHULTE AFTERLOADING CATHETER is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is American Heyer Schulte. The 510(k) number is K832738.

When did HEYER-SCHULTE AFTERLOADING CATHETER receive FDA 510(k) clearance?

HEYER-SCHULTE AFTERLOADING CATHETER received FDA 510(k) clearance on 1983-09-29, under 510(k) number K832738.

Who is the listed applicant for HEYER-SCHULTE AFTERLOADING CATHETER?

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

What is the FDA product code for HEYER-SCHULTE AFTERLOADING CATHETER?

The FDA product code for HEYER-SCHULTE AFTERLOADING CATHETER is IWJ.

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 Heyer Schulte 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.

K840172VENTRAL WALL DEFECT REDUCT SILOK834593ONE-PIECE SHUNTK833502RADOVAN SUBCUTANEOUS TISSUE EXPANDERK833698AMER. V. MUELLER SURG. STAPLES ILAK833704AMER. V. MUELLER SURGICALSTAPLES-CARTRK823790VENTRICULAR ACCESS SYSTEM

View all 13 devices →

Related Devices (Code: IWJ)

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.

K010166IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEMImagyn Medical Technologies, Inc.K980997PGK DEVICE (MODIFIED)Pgk, Inc.K972554REGANES RADIONUCLIDE SEED MAGAZINEAvid N.I.T., Inc.K973037N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000Avid N.I.T., Inc.K974118WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SETWorldwide Medical Technologies, LLCK973786NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDENw Radiation Therapy Products

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.

↑