Home / 510(k) Clearances / K820247

510(k) K820247

EXTERNAL VENTRICULAR DRAINAGE SYS. by American Heyer Schulte — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1982
Date Received
January 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

Other clearances by American Heyer Schulte

  • K840172 — VENTRAL WALL DEFECT REDUCT SILO (June 27, 1984)
  • K834593 — ONE-PIECE SHUNT (April 3, 1984)
  • K833502 — RADOVAN SUBCUTANEOUS TISSUE EXPANDER (February 3, 1984)
  • K833698 — AMER. V. MUELLER SURG. STAPLES ILA (January 25, 1984)
  • K833704 — AMER. V. MUELLER SURGICALSTAPLES-CARTR (December 29, 1983)
  • K832738 — HEYER-SCHULTE AFTERLOADING CATHETER (September 29, 1983)
  • K823790 — VENTRICULAR ACCESS SYSTEM (April 28, 1983)
  • K822096 — CHEMOTHERAPY INFUSION CATHETER (April 12, 1983)
  • K822032 — LARGE VOLUME CLOSED WOUND SUCTION DRAIN (August 16, 1982)
  • K811288 — SPETZLER LUMBAR-PERITONEAL SYSTEM (June 26, 1981)

Other clearances for product code JXG

  • K251598 — Intellidrop (December 10, 2025)
  • K250636 — Sophy Mini Monopressure Valve (SM1) (November 28, 2025)
  • K252514 — EVAC-MRI (November 5, 2025)
  • K243531 — Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (August 8, 2025)
  • K243552 — Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with (August 6, 2025)
  • K242974 — External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Cathet (June 20, 2025)
  • K243205 — EVAC (June 3, 2025)
  • K243676 — Duet External Drainage and Monitoring System (EDMS) (March 10, 2025)
  • K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (December 16, 2024)
  • K241458 — Borvo EVAC System (Ergo); Borvo EVAC System (Classic) (August 20, 2024)