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FDA 510(k)

URINARY CATHETER SAMPLING KIT

K-Number: K800946 · 1980-06-20

ApplicantSage Products, Inc.
Decision Date1980-06-20
Product CodeKDT
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

URINARY CATHETER SAMPLING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sage Products, Inc.. It received FDA 510(k) clearance on 1980-06-20 under 510(k) number K800946. The device is classified under product code KDT. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINARY CATHETER SAMPLING KIT?

URINARY CATHETER SAMPLING KIT is a medical device that received FDA 510(k) clearance on 1980-06-20. The listed applicant is Sage Products, Inc.. The 510(k) number is K800946.

When did URINARY CATHETER SAMPLING KIT receive FDA 510(k) clearance?

URINARY CATHETER SAMPLING KIT received FDA 510(k) clearance on 1980-06-20, under 510(k) number K800946.

Who is the listed applicant for URINARY CATHETER SAMPLING KIT?

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

What is the FDA product code for URINARY CATHETER SAMPLING KIT?

The FDA product code for URINARY CATHETER SAMPLING KIT is KDT.

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Other records listing Sage Products, Inc. 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.

K972705RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTICK980490SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPSK9739112 GALLON ALTERNATE CARE SHARPS CONTAINERK972279SHARPS SHUTTLEK970135NITRILE GLOVESK972302POCKET COUNT OR SAFETCOUNT

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Related Devices (Code: KDT)

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.

K873593BIOSURE SPECIMEN COLLECTION CONTAINERBiosure, Inc.K862665NOVACYTE-UXsirius Medical, Inc.K834579BIOSPAL 2400SHospal Medical Corp.K834412PRESERV PVA FIXATIVE 15ML-FORMALIN PKPreventive Diagnostics Corp.K833660PRESERV PVA FIXATIVE -MALIN PACKPreventive Diagnostics Corp.K823773PROVIAL II #006-010-0201Dynatech Corp.

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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