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Innervision 27065 C

by Medtronic PS Medical 2 variants

Innervision 27065 C is a Class II device made by Medtronic PS Medical, cleared under FDA 510(k) K983331 on 16 Dec 1998 and listed in FDA GUDID since 25 Jun 2015 (UDI-DI 00643169483880), active as of 22 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 ongoing

29 closed

Documents

510(k) K983331

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169483880 UDI-DI Date25 Jun 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK983331 Date16 Dec 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K983331 decided 16 Dec 1998 Active
  • FDA GUDID UDI-DI 00643169483880 listed 25 Jun 2015 Listed

Recalls

29 recalls · FDA

  • 29 recalls, same reason

    • Terminated Z-1146-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1128-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1150-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1132-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1124-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1151-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1129-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1149-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1131-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1126-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1135-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1137-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1125-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1139-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1142-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1148-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1144-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1134-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1127-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1143-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1147-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1145-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1141-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1136-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1140-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1138-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1130-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1133-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331
    • Terminated Z-1152-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 on shared 510(k) K983331

    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.

Timeline

31 dated events

  1. Recall initiated FDA recalls Z-1147-2009
  2. Recall initiated FDA recalls Z-1145-2009
  3. Recall initiated FDA recalls Z-1141-2009
  4. Recall initiated FDA recalls Z-1136-2009
  5. Recall initiated FDA recalls Z-1140-2009
  6. Recall initiated FDA recalls Z-1138-2009
  7. Recall initiated FDA recalls Z-1130-2009
  8. Recall initiated FDA recalls Z-1133-2009
  9. Recall initiated FDA recalls Z-1152-2009
  10. Listed FDA GUDID 00643169483880

21 earlier events are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Innervision
Generic name
Intracerebral infusion/drainage catheter, long-term
Model / reference
27065 C
Primary DI / UDI-DI
00643169483880
510(k) Number
FDA product code
LKG
GMDN term
Intracerebral infusion/drainage catheter, long-term
Device class
Class II
Regulation number
882.5550
GUDID distribution status
In Commercial Distribution
Size
Length — 6.0 Centimeter

Related devices

Category: Intracerebral infusion/drainage catheter, long-term

Cleared under the same submission (K983331)

and 8 more cleared under K983331

Similar devices in this category

Other devices filed under Intracerebral infusion/drainage catheter, long-term.

Other devices from Medtronic PS Medical

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  • Innervision 27065 D

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See all devices from Medtronic PS Medical →

Properties

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