FDA 510(k)

RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS

K-Number: K060288 · 2006-09-01

Decision Date2006-09-01

Product CodeMSD

Advisory CommitteeGU

DecisionUnknown

Device Summary

RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS 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 2006-09-01 under 510(k) number K060288. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS?

RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS is a medical device that received FDA 510(k) clearance on 2006-09-01. The listed applicant is Spire Biomedical, Inc.. The 510(k) number is K060288.

When did RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS receive FDA 510(k) clearance?

RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS received FDA 510(k) clearance on 2006-09-01, under 510(k) number K060288.

Who is the listed applicant for RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS?

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 RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS?

The FDA product code for RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS 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 K06015515.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS

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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.