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FDA 510(k)

REEFLEX PTA CATHETER

K-Number: K101361 · 2010-08-04

ApplicantClearStream Technologies , Ltd.
Decision Date2010-08-04
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REEFLEX PTA CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is ClearStream Technologies , Ltd.. It received FDA 510(k) clearance on 2010-08-04 under 510(k) number K101361. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REEFLEX PTA CATHETER?

REEFLEX PTA CATHETER is a medical device that received FDA 510(k) clearance on 2010-08-04. The listed applicant is ClearStream Technologies , Ltd.. The 510(k) number is K101361.

When did REEFLEX PTA CATHETER receive FDA 510(k) clearance?

REEFLEX PTA CATHETER received FDA 510(k) clearance on 2010-08-04, under 510(k) number K101361.

Who is the listed applicant for REEFLEX PTA CATHETER?

The FDA 510(k) record lists ClearStream Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REEFLEX PTA CATHETER?

The FDA product code for REEFLEX PTA CATHETER is LIT.

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Other records listing ClearStream Technologies , Ltd. as applicant

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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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