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FDA 510(k)

CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER

K-Number: K102589 · 2011-01-14

ApplicantCodman & Shurtleff, Inc.
Decision Date2011-01-14
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2011-01-14 under 510(k) number K102589. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER?

CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER is a medical device that received FDA 510(k) clearance on 2011-01-14. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K102589.

When did CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER receive FDA 510(k) clearance?

CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER received FDA 510(k) clearance on 2011-01-14, under 510(k) number K102589.

Who is the listed applicant for CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER?

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

What is the FDA product code for CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER?

The FDA product code for CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER is JXG.

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Related Devices (Code: JXG)

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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