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Pacific™ Plus PCP020080150

by Medtronic, Inc. 2 variants

Pacific™ Plus PCP020080150 is a Class II device made by Medtronic, Inc., cleared under FDA 510(k) K123358 on 29 Jan 2013 and listed in FDA GUDID since 1 Feb 2018 (UDI-DI 08033477071619), 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) K123358

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 Number08033477071619 UDI-DI Date1 Feb 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123358 Date29 Jan 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123358 decided 29 Jan 2013 Active
  • FDA GUDID UDI-DI 08033477071619 listed 1 Feb 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123358
  2. Listed FDA GUDID 08033477071619

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pacific™ Plus
Generic name
Peripheral angioplasty balloon catheter, basic
Model / reference
PCP020080150
Primary DI / UDI-DI
08033477071619
510(k) Number
FDA product code
LIT, DQY
GMDN term
Peripheral angioplasty balloon catheter, basic
Device class
Class II
Regulation number
870.1250
GUDID distribution status
In Commercial Distribution
Size
Length — 80.0 Millimeter
Outer Diameter — 2.0 Millimeter

Related devices

Category: Peripheral angioplasty balloon catheter, basic

Cleared under the same submission (K123358)

and 8 more cleared under K123358

Similar devices in this category

Other devices filed under Peripheral angioplasty balloon catheter, basic.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)