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FDA 510(k)

PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS

K-Number: K021591 · 2002-05-22

ApplicantCordis Neurovascular, Inc.
Decision Date2002-05-22
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Neurovascular, Inc.. It received FDA 510(k) clearance on 2002-05-22 under 510(k) number K021591. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS?

PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS is a medical device that received FDA 510(k) clearance on 2002-05-22. The listed applicant is Cordis Neurovascular, Inc.. The 510(k) number is K021591.

When did PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS receive FDA 510(k) clearance?

PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS received FDA 510(k) clearance on 2002-05-22, under 510(k) number K021591.

Who is the listed applicant for PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS?

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

What is the FDA product code for PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS?

The FDA product code for PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS is KRA.

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Related Devices (Code: KRA)

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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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