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DABRA 101 Catheter

by Catheter Precision, Inc

DABRA 101 Catheter is an atherectomy laser system beam guide-catheter (FDA Class II; FDA product code PDU, Catheter For Crossing Total Occlusions) made by Catheter Precision, Inc, cleared under FDA 510(k) K170349 on 24 May 2017 and listed in FDA GUDID since 13 Oct 2017 (UDI-DI 00842362100031), active as of 21 Oct 2026. 5 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

Documents

510(k) K170349

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00842362100031 UDI-DI Date13 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170349 Date24 May 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170349 decided 24 May 2017 Active
  • FDA GUDID UDI-DI 00842362100031 listed 13 Oct 2017 Listed

Recalls

5 recalls · FDA

    • Terminated Z-0569-2021 FDA Class II initiated 16 Oct 2020

    Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the laser to continue to lase.

    • Terminated Z-0050-2021 FDA Class II initiated 24 Jul 2020

    Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.

    • Terminated Z-2497-2020 FDA Class II initiated 23 Jan 2020

    A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient.

    • Terminated Z-2006-2020 FDA Class II initiated 19 Sep 2019

    The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently less than the labeled shelf life.

    • Terminated Z-2218-2019 FDA Class II initiated 15 Feb 2018

    Lasers/Catheters did not calibrate during set-up prior to use.

Timeline

7 dated events

  1. Cleared FDA 510(k) K170349
  2. Listed FDA GUDID 00842362100031
  3. Recall initiated FDA recalls Z-2218-2019
  4. Recall initiated FDA recalls Z-2006-2020
  5. Recall initiated FDA recalls Z-2497-2020
  6. Recall initiated FDA recalls Z-0050-2021
  7. Recall initiated FDA recalls Z-0569-2021

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Atherectomy laser system beam guide-catheter, peripheral
Model / reference
101
Primary DI / UDI-DI
00842362100031
510(k) Number
FDA product code
PDU
GMDN term
Atherectomy laser system beam guide-catheter, peripheral
Device class
Class II
Regulation number
870.1250
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Related devices

Category: Atherectomy laser system beam guide-catheter, peripheral

Cleared under the same submission (K170349)

Similar devices

Other devices filed under FDA product code PDU (Catheter For Crossing Total Occlusions).

Other devices from Catheter Precision, Inc

See all devices from Catheter Precision, Inc →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)