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Csf-Ventriculostomy Reservoir

by Pudenz-Schulte Medical Research Corp.

510(k) K874498

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

29 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK874498 Date11 Feb 1988ClearedStatusActive

Recalls

29 recalls · FDA

  • 29 recalls, same reason

    • Terminated Z-1146-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1128-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1150-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1132-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1124-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1151-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1129-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1149-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1131-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1126-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1135-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1137-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1125-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1139-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1142-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1148-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1144-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1134-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1127-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1143-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1147-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1145-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1141-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1136-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1140-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1138-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1130-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1133-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498
    • Terminated Z-1152-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K874498

    The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LKG
Device Class
Class II
Regulation
21 CFR Part 882.5550
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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