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Celsius DS D7TCD8L162RT

by Biosense Webster Inc

Celsius DS D7TCD8L162RT is a Class III device made by Biosense Webster Inc, approved under FDA PMA P010068 on 27 Sep 2002 and listed in FDA GUDID since 17 Sep 2014 (UDI-DI 10846835006124), active as of 23 Oct 2026.

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

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

PMA P010068

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 Number10846835006124 UDI-DI Date17 Sep 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP010068 Date27 Sep 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P010068 decided 27 Sep 2002 Active
  • FDA GUDID UDI-DI 10846835006124 listed 17 Sep 2014 Listed

Timeline

2 dated events

  1. Approved FDA PMA P010068
  2. Listed FDA GUDID 10846835006124

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
Celsius DS
Generic name
Cardiac radio-frequency ablation system catheter
Model / Ref / Catalog
D7TCD8L162RT
Primary DI / UDI-DI
10846835006124
PMA number
FDA product code
OAD
GMDN term
Cardiac radio-frequency ablation system catheter
Device class
Class III
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Cardiac radio-frequency ablation system catheter.

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Properties

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