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FDA 510(k)

ACCU-LEAD

K-Number: K050443 · 2005-09-02

ApplicantKentec Medical, Inc.
Decision Date2005-09-02
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACCU-LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Kentec Medical, Inc.. It received FDA 510(k) clearance on 2005-09-02 under 510(k) number K050443. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-LEAD?

ACCU-LEAD is a medical device that received FDA 510(k) clearance on 2005-09-02. The listed applicant is Kentec Medical, Inc.. The 510(k) number is K050443.

When did ACCU-LEAD receive FDA 510(k) clearance?

ACCU-LEAD received FDA 510(k) clearance on 2005-09-02, under 510(k) number K050443.

Who is the listed applicant for ACCU-LEAD?

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

What is the FDA product code for ACCU-LEAD?

The FDA product code for ACCU-LEAD is DRX.

Other records listing Kentec Medical, 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.

K120272AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SETK100526AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBEK970686ACCUTEMP-PROBEK960080ACCUTEMP PROBEK853475GRAM-MA NEONATAL SC

Related Devices (Code: DRX)

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.

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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.

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