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FDA 510(k)

SHADOW-CATHS

K-Number: K780643 · 1978-04-27

ApplicantQuinton, Inc.
Decision Date1978-04-27
Product CodeFJS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SHADOW-CATHS is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1978-04-27 under 510(k) number K780643. The device is classified under product code FJS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHADOW-CATHS?

SHADOW-CATHS is a medical device that received FDA 510(k) clearance on 1978-04-27. The listed applicant is Quinton, Inc.. The 510(k) number is K780643.

When did SHADOW-CATHS receive FDA 510(k) clearance?

SHADOW-CATHS received FDA 510(k) clearance on 1978-04-27, under 510(k) number K780643.

Who is the listed applicant for SHADOW-CATHS?

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

What is the FDA product code for SHADOW-CATHS?

The FDA product code for SHADOW-CATHS is FJS.

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Other records listing Quinton, 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.

K032038PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601K021906QUINTON Q-CATH, MODEL 000460K003576Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503K001492QUINTON Q-STRESS, MODEL 000483K992908Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)K990866QUINTON MEDTRACK CR PLUS TREADMILL

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Related Devices (Code: FJS)

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.

K213602Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool KitCovidien, LLCK180485Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter ExtenderCovidien, LLCK130441FALLER STYLETMedionics International, Inc.K121383PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)Medical Components, Inc.K120130FALLER TROCARMedigroup, Inc.K113354VETA PERITONEAL DIALYSIS CATHETERPfm 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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