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FDA 510(k)

BANTAM CATHETER (280MM BALLOON LENGTHS)

K-Number: K112335 · 2011-10-12

ApplicantClearStream Technologies , Ltd.
Decision Date2011-10-12
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BANTAM CATHETER (280MM BALLOON LENGTHS) 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 2011-10-12 under 510(k) number K112335. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BANTAM CATHETER (280MM BALLOON LENGTHS)?

BANTAM CATHETER (280MM BALLOON LENGTHS) is a medical device that received FDA 510(k) clearance on 2011-10-12. The listed applicant is ClearStream Technologies , Ltd.. The 510(k) number is K112335.

When did BANTAM CATHETER (280MM BALLOON LENGTHS) receive FDA 510(k) clearance?

BANTAM CATHETER (280MM BALLOON LENGTHS) received FDA 510(k) clearance on 2011-10-12, under 510(k) number K112335.

Who is the listed applicant for BANTAM CATHETER (280MM BALLOON LENGTHS)?

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 BANTAM CATHETER (280MM BALLOON LENGTHS)?

The FDA product code for BANTAM CATHETER (280MM BALLOON LENGTHS) is DQY.

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Other records listing ClearStream Technologies , Ltd. 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.

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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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