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FDA 510(k)

DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)

K-Number: K210664 · 2021-07-27

ApplicantRa Medical Systems,Inc
Decision Date2021-07-27
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) is the device name listed in this FDA 510(k) record. The listed applicant is Ra Medical Systems,Inc. It received FDA 510(k) clearance on 2021-07-27 under 510(k) number K210664. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)?

DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) is a medical device that received FDA 510(k) clearance on 2021-07-27. The listed applicant is Ra Medical Systems,Inc. The 510(k) number is K210664.

When did DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) receive FDA 510(k) clearance?

DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) received FDA 510(k) clearance on 2021-07-27, under 510(k) number K210664.

Who is the listed applicant for DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)?

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

What is the FDA product code for DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)?

The FDA product code for DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) is PDU.

Other records listing Ra Medical Systems,Inc 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.

K220544DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)K170349RA-308 Excimer Laser System, Excimer Laser Catheter

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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