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510(k) K833672

HH SUBCUTANEOUS ACCESS PORT by Holter-Hausner Intl. — Product Code LKG

K833672 is an FDA 510(k) premarket notification submitted by Holter-Hausner Intl. for the device "HH SUBCUTANEOUS ACCESS PORT". The FDA issued a decision of Substantially Equivalent on March 6, 1984. The device falls under product code LKG (Port & Catheter, Implanted, Subcutaneous, Intraventricular), a Class II device regulated under 21 CFR 882.5550. Holter-Hausner Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1984
Date Received
October 18, 1983
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 Holter-Hausner Intl.

  • K875287 — H-H FLUSHING RESERVOIR (July 14, 1988)
  • K874508 — H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG (January 19, 1988)
  • K872285 — H-H HUNTER ACTIVE TENDON IMPLANT DC (September 28, 1987)
  • K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PC (September 28, 1987)
  • K872293 — H-H HUNTER ACTIVE TENDON IMPLANT BC (September 28, 1987)
  • K871351 — H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP (May 14, 1987)
  • K870660 — H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS (May 1, 1987)
  • K865075 — H-H SUBGALEAL TROCAR (January 13, 1987)
  • K853436 — H-H HUNTER PASSIVE TENDON IMPLANT (October 16, 1985)
  • K853437 — H-H HUNTER TENDON ROD (October 16, 1985)

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)
  • K823790 — VENTRICULAR ACCESS SYSTEM (April 28, 1983)

FDA data resources