REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS— 510(k) K062435

Name: FDA 510(k) clearance K062435
Creator: U.S. Food and Drug Administration
Published: 2006-12-05

Substantially Equivalent

Spire Biomedical, Inc.

FDA 510(k) clearance K062435 for REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS, Substantially Equivalent on 2006-12-05. Applicant: Spire Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Spire Biomedical, Inc.
Product code: Code NFK
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 2006-08-21
Decision date: 2006-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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K073093 — DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,2008-01-22
K063441 — 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH552007-02-12
K063431 — 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH402007-01-29
K060288 — RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS2006-09-01

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