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BioGlide® 27536

by Medtronic PS Medical 2 variants

BioGlide® 27536 is a Class II device made by Medtronic PS Medical, cleared under FDA 510(k) K951258 on 18 Sep 1995 and listed in FDA GUDID since 19 Mar 2020 (UDI-DI 00763000028916), active as of 23 Oct 2026. 31 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

510(k) K951258

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 Number00763000028916 UDI-DI Date19 Mar 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK951258 Date18 Sep 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K951258 decided 18 Sep 1995 Active
  • FDA GUDID UDI-DI 00763000028916 listed 19 Mar 2020 Listed

Recalls

31 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1117-2021 FDA Class II initiated 11 Jan 2021
    • Ongoing Z-1115-2021 FDA Class II initiated 11 Jan 2021

    Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus

  • 29 recalls, same reason

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

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

Timeline

33 dated events

  1. Recall initiated FDA recalls Z-1141-2009
  2. Recall initiated FDA recalls Z-1136-2009
  3. Recall initiated FDA recalls Z-1140-2009
  4. Recall initiated FDA recalls Z-1138-2009
  5. Recall initiated FDA recalls Z-1130-2009
  6. Recall initiated FDA recalls Z-1133-2009
  7. Recall initiated FDA recalls Z-1152-2009
  8. Listed FDA GUDID 00763000028916
  9. Recall initiated FDA recalls Z-1117-2021
  10. Recall initiated FDA recalls Z-1115-2021

23 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
BioGlide®
Generic name
Lumboperitoneal shunt peritoneal catheter
Model / reference
27536
Primary DI / UDI-DI
00763000028916
510(k) Number
FDA product code
JXG
GMDN term
Lumboperitoneal shunt peritoneal catheter
Device class
Class II
Regulation number
882.5550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Lumboperitoneal shunt peritoneal catheter

Cleared under the same submission (K951258)

and 8 more cleared under K951258

Similar devices

Also classified as Lumboperitoneal shunt peritoneal catheter.

Similar devices

Other devices filed under FDA product code JXG (Shunt, central nervous system and components).

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Properties

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