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AQUATRACK™ Hydrophilic Nitinol Guidewire C3526RSA

by Cordis US Corp. GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705032057066 UDI-DIDate29 Jul 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Recalls

52 recalls · FDA

    • Terminated Z-0623-2010 FDA Unclassified (pre-2012) initiated 25 Aug 2009

    Some of the guidewires in these two lots have a straight tip (incorrect) rather than an angled tip (correct configuration for that catalog number).

  • 41 recalls, same reason

    • Terminated Z-1272-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1278-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1280-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1297-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1300-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1270-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1284-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1285-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1292-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1290-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1283-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1299-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1304-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1307-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1288-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1296-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1271-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1281-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1295-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1274-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1269-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1303-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1273-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1275-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1277-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1301-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1305-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1294-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1289-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1267-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1293-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1268-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1291-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1276-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1286-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1298-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1302-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1287-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1306-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1282-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009
    • Terminated Z-1279-2009 FDA Unclassified (pre-2012) initiated 26 Feb 2009

    Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.

  • 10 recalls, same reason

    • Terminated Z-0891-2008 FDA Unclassified (pre-2012) initiated 19 Nov 2007
    • Terminated Z-0883-2008 FDA Unclassified (pre-2012) initiated 19 Nov 2007
    • Terminated Z-0888-2008 FDA Unclassified (pre-2012) initiated 19 Nov 2007
    • Terminated Z-0889-2008 FDA Unclassified (pre-2012) initiated 19 Nov 2007
    • Terminated Z-0885-2008 FDA Unclassified (pre-2012) initiated 19 Nov 2007
    • Terminated Z-0890-2008 FDA Unclassified (pre-2012) initiated 19 Nov 2007
    • Terminated Z-0882-2008 FDA Unclassified (pre-2012) initiated 19 Nov 2007
    • Terminated Z-0886-2008 FDA Unclassified (pre-2012) initiated 19 Nov 2007
    • Terminated Z-0884-2008 FDA Unclassified (pre-2012) initiated 19 Nov 2007
    • Terminated Z-0887-2008 FDA Unclassified (pre-2012) initiated 19 Nov 2007

    Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism.

Specification

GUDID

Trade Name
AQUATRACK™ Hydrophilic Nitinol Guidewire
Generic Name
Cardiac/peripheral vascular guidewire, single-use
Model / Ref / Catalog
C3526RSA
Primary DI / UDI-DI
10705032057066
510(k) Number
FDA Product Code
DQX
GMDN Term
Cardiac/peripheral vascular guidewire, single-use
Device Class
Class II
Regulation Number
870.1330
Commercial Distribution
In Commercial Distribution

Related devices

Cleared under the same submission (K011905)

Other devices from Cordis US Corp.

See all devices from Cordis US Corp. →

Properties

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

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No