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FDA 510(k)

SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER

K-Number: K950042 · 1995-12-15

ApplicantAccurate Surgical Instruments Co.
Decision Date1995-12-15
Product CodeFJS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Accurate Surgical Instruments Co.. It received FDA 510(k) clearance on 1995-12-15 under 510(k) number K950042. 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 SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER?

SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER is a medical device that received FDA 510(k) clearance on 1995-12-15. The listed applicant is Accurate Surgical Instruments Co.. The 510(k) number is K950042.

When did SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER receive FDA 510(k) clearance?

SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER received FDA 510(k) clearance on 1995-12-15, under 510(k) number K950042.

Who is the listed applicant for SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER?

The FDA 510(k) record lists Accurate Surgical Instruments Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER?

The FDA product code for SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER is FJS.

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Other records listing Accurate Surgical Instruments Co. 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.

K920515INSERTIONK910786TROCAR (FALLER STYLET)K910785TITANIUM CATHETER EXTENDERK910787TITANIUM CONNECTOR (2 PART)K862046SWAN-NECK PERITONEAL DIALYSIS CATHETERSK850214STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN

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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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