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Webster D6DR010RT

by Biosense Webster Inc

Webster D6DR010RT is a Class II device made by Biosense Webster Inc, cleared under FDA 510(k) K892265 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 10846835004441), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K892265↗

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10846835004441 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK892265 Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K892265 Active
  • FDA GUDID UDI-DI 10846835004441 listed 16 Sep 2016 Listed

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Webster
Generic name
Cardiac mapping catheter, percutaneous, single-use
Model / Ref / Catalog
D6DR010RT
Primary DI / UDI-DI
10846835004441
510(k) Number
FDA product code
DRF
GMDN term
Cardiac mapping catheter, percutaneous, single-use
Device class
Class II
Regulation number
870.1220
GUDID distribution status
In Commercial Distribution

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Other devices filed under Cardiac mapping catheter, percutaneous, single-use.

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)