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FDA 510(k)

SILICONE ELASTOMER INFUSION CATHETER

K-Number: K813606 · 1982-01-18

ApplicantQuest Medical, Inc.
Decision Date1982-01-18
Product CodeJCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILICONE ELASTOMER INFUSION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Quest Medical, Inc.. It received FDA 510(k) clearance on 1982-01-18 under 510(k) number K813606. 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 SILICONE ELASTOMER INFUSION CATHETER?

SILICONE ELASTOMER INFUSION CATHETER is a medical device that received FDA 510(k) clearance on 1982-01-18. The listed applicant is Quest Medical, Inc.. The 510(k) number is K813606.

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

SILICONE ELASTOMER INFUSION CATHETER received FDA 510(k) clearance on 1982-01-18, under 510(k) number K813606.

Who is the listed applicant for SILICONE ELASTOMER INFUSION CATHETER?

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

What is the FDA product code for SILICONE ELASTOMER INFUSION CATHETER?

The FDA product code for SILICONE ELASTOMER INFUSION CATHETER is JCY.

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Other records listing Quest Medical, Inc. as applicant

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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.K822096CHEMOTHERAPY INFUSION CATHETERAmerican Heyer Schulte

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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