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FDA 510(k)

REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS

K-Number: K062435 · 2006-12-05

ApplicantSpire Biomedical, Inc.
Decision Date2006-12-05
Product CodeNFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR 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 2006-12-05 under 510(k) number K062435. The device is classified under product code NFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS?

REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS is a medical device that received FDA 510(k) clearance on 2006-12-05. The listed applicant is Spire Biomedical, Inc.. The 510(k) number is K062435.

When did REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS receive FDA 510(k) clearance?

REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS received FDA 510(k) clearance on 2006-12-05, under 510(k) number K062435.

Who is the listed applicant for REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR 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 REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS?

The FDA product code for REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS is NFK.

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Other records listing Spire Biomedical, 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.

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, ALC50SH55K06343115.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40K060288RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERSK06015515.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS

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Related Devices (Code: NFK)

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.

K101261CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000C.R. Bard, Inc.K092797ACUTE AND CHRONIC CATHETER REPAIR KITKendallK063446CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000C.R. Bard, Inc.K030442CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000C.R. Bard, Inc.K022644RETRO REPAIR KIT, MODEL PRRK5Spire Biomedical, Inc.K022570MEDCOMP REPAIR KIT, MODEL ASPCRPKMedcomp

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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