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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 a medical device manufactured by Ra Medical Systems,Inc. It received FDA 510(k) clearance on 2021-07-27 under approval 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. It is manufactured by Ra Medical Systems,Inc. The 510(k) number is K210664.

When was DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) approved by the FDA?

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

What company makes 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 manufactured by Ra Medical Systems,Inc.

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.

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Ra Medical Systems,Inc

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

Related Devices (Code: PDU)

K162418Pioneer Plus CatheterPhilips Volcano K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc. K170349RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc K183357XableCath Crossing CatheterXablecath, Inc. K201330Tigereye CTO-Crossing CatheterAvinger, Inc. K192211SoundBite Console, SoundBite Active Wire 18Soundbite Medical Solution, Inc.

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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