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FDA 510(k)

JELCO & KVO CATHETER PLACEMENT UNIT

K-Number: K791372 · 1979-09-12

ApplicantJelco Laboratories
Decision Date1979-09-12
Product CodeJCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

JELCO & KVO CATHETER PLACEMENT UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Jelco Laboratories. It received FDA 510(k) clearance on 1979-09-12 under 510(k) number K791372. 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 JELCO & KVO CATHETER PLACEMENT UNIT?

JELCO & KVO CATHETER PLACEMENT UNIT is a medical device that received FDA 510(k) clearance on 1979-09-12. The listed applicant is Jelco Laboratories. The 510(k) number is K791372.

When did JELCO & KVO CATHETER PLACEMENT UNIT receive FDA 510(k) clearance?

JELCO & KVO CATHETER PLACEMENT UNIT received FDA 510(k) clearance on 1979-09-12, under 510(k) number K791372.

Who is the listed applicant for JELCO & KVO CATHETER PLACEMENT UNIT?

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

What is the FDA product code for JELCO & KVO CATHETER PLACEMENT UNIT?

The FDA product code for JELCO & KVO CATHETER PLACEMENT UNIT is JCY.

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Other records listing Jelco Laboratories 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.

K791918JELCO WINGED INTRAVASCULAR CATHETERK790967CATHETER METAL HUB/RADIOPAQUEK790968CATHETER METAL HUB/NONRADIOPAQUEK790471JELCO* DISC FILTER-0.2 MICRONK790186PROTECTIVSTABILIZERK790079NEEDLE, BLOOD COLLECTING

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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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