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Advance® 14LP

by Cook Incorporated

Ref PTAX4-14-170-3-12, PTAX4-14-170-2-4, PTAX4-14-170-4-2, PTAX4-14-170-2.5-6, PTAX4-14-170-2.5-2, PTAX4-14-170-4-4, PTAX4-14-170-4-20, PTAX4-14-170-3-16, PTAX4-14-170-2-8, PTAX4-14-170-2.5-12, PTAX4-14-170-2-12, PTAX4-14-170-3-20, PTAX4-14-170-2.5-16, PTAX4-14-170-3-8, PTAX4-14-170-3-2510(k) K170193

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170193↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00827002503311 Basic UDI-DI Date26 Mar 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK170193 Date13 Feb 2017ClearedStatusActive
United StatesGUDID listing GUDID Number00827002503311 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Advance® 14LP EUDAMED
Advance GUDID
Generic Name
Peripheral angioplasty balloon catheter, basic
Model / Ref / Catalog
PTAX4-14-170-3-12, PTAX4-14-170-2-4, PTAX4-14-170-4-2, PTAX4-14-170-2.5-6, PTAX4-14-170-2.5-2, PTAX4-14-170-4-4, PTAX4-14-170-4-20, PTAX4-14-170-3-16, PTAX4-14-170-2-8, PTAX4-14-170-2.5-12, PTAX4-14-170-2-12, PTAX4-14-170-3-20, PTAX4-14-170-2.5-16, PTAX4-14-170-3-8, PTAX4-14-170-3-2, G50340, G50327, G50314, G50334, G50332, G50333, G50320, G50317, G50335, G50325, G50322, G50316, G50324, G50330, G50331
Primary DI / UDI-DI
00827002503311 EUDAMED
00827002503144 EUDAMED
00827002503342 EUDAMED
00827002503229 EUDAMED
00827002503205 EUDAMED
00827002503359 EUDAMED
00827002503403 EUDAMED
00827002503328 EUDAMED
00827002503168 EUDAMED
00827002503243 EUDAMED
00827002503175 EUDAMED
00827002503335 EUDAMED
00827002503250 EUDAMED
00827002503304 EUDAMED
00827002503274 EUDAMED
10827002503400 GUDID
10827002503271 GUDID
10827002503141 GUDID
10827002503349 GUDID
10827002503325 GUDID
10827002503332 GUDID
10827002503202 GUDID
10827002503172 GUDID
10827002503356 GUDID
10827002503257 GUDID
10827002503226 GUDID
10827002503165 GUDID
10827002503240 GUDID
10827002503301 GUDID
10827002503318 GUDID
Basic UDI-DI
B-00827002503311, B-00827002503144, B-00827002503342, B-00827002503229, B-00827002503205, B-00827002503359, B-00827002503403, B-00827002503328, B-00827002503168, B-00827002503243, B-00827002503175, B-00827002503335, B-00827002503250, B-00827002503304, B-00827002503274
510(k) Number
FDA Product Code
LIT
EMDN Code
C010402020101 PTA balloon dilatation catheters
GMDN Term
Peripheral angioplasty balloon catheter, basic
Device Class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 870.1250
EU market of registration
Germany
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 3 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
PTAX4-14-170-3-12
PTAX4-14-170-2-4
PTAX4-14-170-4-2
PTAX4-14-170-2.5-6
PTAX4-14-170-2.5-2
PTAX4-14-170-4-4
PTAX4-14-170-4-20
PTAX4-14-170-3-16
PTAX4-14-170-2-8
PTAX4-14-170-2.5-12
PTAX4-14-170-2-12
PTAX4-14-170-3-20
PTAX4-14-170-2.5-16
PTAX4-14-170-3-8
PTAX4-14-170-3-2
510(k)
—
GUDID
G50340
G50327
G50314
G50334
G50332
G50333
G50320
G50317
G50335
G50325
G50322
G50316
G50324
G50330
G50331
Primary DI / UDI-DIEUDAMED
00827002503311
00827002503144
00827002503342
00827002503229
00827002503205
00827002503359
00827002503403
00827002503328
00827002503168
00827002503243
00827002503175
00827002503335
00827002503250
00827002503304
00827002503274
510(k)
—
GUDID
10827002503400
10827002503271
10827002503141
10827002503349
10827002503325
10827002503332
10827002503202
10827002503172
10827002503356
10827002503257
10827002503226
10827002503165
10827002503240
10827002503301
10827002503318
Device ClassEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000003180
Authorised representative
COOK MEDICAL EUROPE LIMITED IE-AR-000000907

Related devices

Category: Peripheral angioplasty balloon catheter, basic

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No