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FDA 510(k)

CHEMOTHERAPY INFUSION CATHETER

K-Number: K822096 · 1983-04-12

ApplicantAmerican Heyer Schulte
Decision Date1983-04-12
Product CodeJCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CHEMOTHERAPY INFUSION 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 1983-04-12 under 510(k) number K822096. The device is classified under product code JCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEMOTHERAPY INFUSION CATHETER?

CHEMOTHERAPY INFUSION CATHETER is a medical device that received FDA 510(k) clearance on 1983-04-12. The listed applicant is American Heyer Schulte. The 510(k) number is K822096.

When did CHEMOTHERAPY INFUSION CATHETER receive FDA 510(k) clearance?

CHEMOTHERAPY INFUSION CATHETER received FDA 510(k) clearance on 1983-04-12, under 510(k) number K822096.

Who is the listed applicant for CHEMOTHERAPY INFUSION 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 CHEMOTHERAPY INFUSION CATHETER?

The FDA product code for CHEMOTHERAPY INFUSION CATHETER is JCY.

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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-CARTRK832738HEYER-SCHULTE AFTERLOADING CATHETER

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Related Devices (Code: JCY)

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.

K863982VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAYVas-Cath of Canada , Ltd.K840324SILICONE SUMP DRAIN 20 & 40 FRENCHSuperior Plastic Products Corp.K834615TRIPLE LUMEN INFUSIONCATHETERS-Medical Components, Inc.K831453SILCATH CENTRAL CATHETER TRAY W/18 GAArgon Medical Corp.K831451SILCATH CENTRAL CATHETER TRAY SIZE-Argon Medical Corp.K813606SILICONE ELASTOMER INFUSION CATHETERQuest Medical, 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.

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