FDA 510(k)

POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER

K-Number: K013160 · 2002-04-11

Decision Date2002-04-11

Product CodeMSD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Spire Biomedical, Inc.. It received FDA 510(k) clearance on 2002-04-11 under 510(k) number K013160. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER?

POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER is a medical device that received FDA 510(k) clearance on 2002-04-11. The listed applicant is Spire Biomedical, Inc.. The 510(k) number is K013160.

When did POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER receive FDA 510(k) clearance?

POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER received FDA 510(k) clearance on 2002-04-11, under 510(k) number K013160.

Who is the listed applicant for POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER?

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

What is the FDA product code for POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER?

The FDA product code for POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER is MSD.

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Other records listing Spire Biomedical, Inc. as applicant

K073092DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,K073093DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,K06344115.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 K06343115.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 K062435REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS K060288RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS

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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.