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FDA 510(k)

ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD

K-Number: K011056 · 2001-10-24

ApplicantArrow Intl., Inc.
Decision Date2001-10-24
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Intl., Inc.. It received FDA 510(k) clearance on 2001-10-24 under 510(k) number K011056. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD?

ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD is a medical device that received FDA 510(k) clearance on 2001-10-24. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K011056.

When did ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD receive FDA 510(k) clearance?

ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD received FDA 510(k) clearance on 2001-10-24, under 510(k) number K011056.

Who is the listed applicant for ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD?

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

What is the FDA product code for ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD?

The FDA product code for ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD is QEW.

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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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