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FDA 510(k)

MIROMED PERITONEAL DIALYSIS CATHETER

K-Number: K810236 · 1981-03-13

ApplicantAmerican Medical Products, Inc.
Decision Date1981-03-13
Product CodeFJS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MIROMED PERITONEAL DIALYSIS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Products, Inc.. It received FDA 510(k) clearance on 1981-03-13 under 510(k) number K810236. 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 MIROMED PERITONEAL DIALYSIS CATHETER?

MIROMED PERITONEAL DIALYSIS CATHETER is a medical device that received FDA 510(k) clearance on 1981-03-13. The listed applicant is American Medical Products, Inc.. The 510(k) number is K810236.

When did MIROMED PERITONEAL DIALYSIS CATHETER receive FDA 510(k) clearance?

MIROMED PERITONEAL DIALYSIS CATHETER received FDA 510(k) clearance on 1981-03-13, under 510(k) number K810236.

Who is the listed applicant for MIROMED PERITONEAL DIALYSIS CATHETER?

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

What is the FDA product code for MIROMED PERITONEAL DIALYSIS CATHETER?

The FDA product code for MIROMED PERITONEAL DIALYSIS CATHETER is FJS.

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Other records listing American Medical 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.

K922290SINGLE-STEP PREGNANCY, HCG TESTK862221E-Z CLEANK861251AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011NK830881AMPERCIDE DISINFECTANT ACCESSORY TO -K823827AMP 80/2 OUTFLOW MONITOR MODIFICATIONK822543CAPD SAFE LOCK TRANSFER SET

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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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