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FDA 510(k)

RETRO REPAIR KIT, MODEL PRRK5

K-Number: K022644 · 2002-11-06

ApplicantSpire Biomedical, Inc.
Decision Date2002-11-06
Product CodeNFK
Advisory CommitteeGU
DecisionUnknown

Device Summary

RETRO REPAIR KIT, MODEL PRRK5 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 2002-11-06 under 510(k) number K022644. The device is classified under product code NFK. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the RETRO REPAIR KIT, MODEL PRRK5?

RETRO REPAIR KIT, MODEL PRRK5 is a medical device that received FDA 510(k) clearance on 2002-11-06. The listed applicant is Spire Biomedical, Inc.. The 510(k) number is K022644.

When did RETRO REPAIR KIT, MODEL PRRK5 receive FDA 510(k) clearance?

RETRO REPAIR KIT, MODEL PRRK5 received FDA 510(k) clearance on 2002-11-06, under 510(k) number K022644.

Who is the listed applicant for RETRO REPAIR KIT, MODEL PRRK5?

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 REPAIR KIT, MODEL PRRK5?

The FDA product code for RETRO REPAIR KIT, MODEL PRRK5 is NFK.

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Other records listing Spire Biomedical, Inc. as applicant

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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.K062435REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERSSpire Biomedical, Inc.K030442CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000C.R. Bard, 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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