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510(k) K823790

VENTRICULAR ACCESS SYSTEM by American Heyer Schulte — Product Code LKG

K823790 is an FDA 510(k) premarket notification submitted by American Heyer Schulte for the device "VENTRICULAR ACCESS SYSTEM". The FDA issued a decision of Substantially Equivalent on April 28, 1983. The device falls under product code LKG (Port & Catheter, Implanted, Subcutaneous, Intraventricular), a Class II device regulated under 21 CFR 882.5550. American Heyer Schulte has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1983
Date Received
December 16, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intraventricular
Device Class
Class II
Regulation Number
882.5550
Review Panel
HO
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)
  • K822096 — CHEMOTHERAPY INFUSION CATHETER (April 12, 1983)
  • K822032 — LARGE VOLUME CLOSED WOUND SUCTION DRAIN (August 16, 1982)
  • K820247 — EXTERNAL VENTRICULAR DRAINAGE SYS. (February 18, 1982)
  • K811288 — SPETZLER LUMBAR-PERITONEAL SYSTEM (June 26, 1981)

Other clearances for product code LKG

  • K950315 — CORDIS CSF RESERVOIR (May 9, 1995)
  • K881690 — PORT-A-CATH PORTAL INTRODUCER FORCEPS (May 20, 1988)
  • K881493 — PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF. (May 20, 1988)
  • K874468 — P-S MEDICAL VENTRICULAR ACCESS PORT (February 11, 1988)
  • K874498 — CSF-VENTRICULOSTOMY RESERVOIR (February 11, 1988)
  • K833822 — P-S MEDICAL CSF ACCESS DEV 15MM/25MM (May 25, 1984)
  • K833672 — HH SUBCUTANEOUS ACCESS PORT (March 6, 1984)

FDA data resources