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FDA 510(k)

THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101

K-Number: K831424 · 1983-10-14

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1983-10-14
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1983-10-14 under 510(k) number K831424. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101?

THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K831424.

When did THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 receive FDA 510(k) clearance?

THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 received FDA 510(k) clearance on 1983-10-14, under 510(k) number K831424.

Who is the listed applicant for THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101?

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

What is the FDA product code for THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101?

The FDA product code for THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 is FJK.

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Other records listing Extracorporeal Medical Specialities, 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.

K843955EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATORK840262HANCOCK PERICARDIAL PATCHK840532HEMOPERFUSION SYSTEM TP-400K840057EXP* 500 PARALLEL PLATE DIALYZERK840146EXP* 700 PARALLEL PLATE DIALYZERK832547ULTRAFILTRATION CONTROLLER

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Related Devices (Code: FJK)

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.

K252423NovaLine Tubing Set for Hemodialysis (BL 124)Bain Medical Equipment (Guangzhou) Co., Ltd.K251341VITAL Tubing Sets for HemodialysisVital Healthcare Sdn. Bhd.K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd.K243607Moda-flx Hemodialysis System™ Cartridge (102121-001 )Diality, Inc.K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCK210782Tablo CartridgeOutset 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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