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510(k) K854593

NORFOLK MEDICAL PERITONEAL-ACCESS PORT by Norfolk Medical Products, Inc. — Product Code LMQ

K854593 is an FDA 510(k) premarket notification submitted by Norfolk Medical Products, Inc. for the device "NORFOLK MEDICAL PERITONEAL-ACCESS PORT". The FDA issued a decision of Substantially Equivalent on Feb 4, 1986. The device falls under product code LMQ (Device, Peritoneal Access, Subcutaneous, Implanted), a Class III device. Norfolk Medical Products, Inc. has 19 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 4, 1986
Date Received
Nov 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Peritoneal Access, Subcutaneous, Implanted
Device Class
Class III
Review Panel
HO
Submission Type
Contact ODE

Other clearances by Norfolk Medical Products, Inc.

  • K192291 — TidalPort-AP Implantable Apheresis Vascular Access Port (Aug 20, 2020)
  • K112713 — NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS (Oct 27, 2011)
  • K102385 — NORFOLK MEDICAL NORPORT FAMILY OF PORTS (Jan 14, 2011)
  • K942784 — NORFOLK OMEGA PORT-LP SUBCUTANEOUSLY IMPLANTED (May 2, 1995)
  • K896544 — MD2 PERSONAL INFUSION SYSTEM (May 2, 1990)
  • K872838 — NORFOLK NORPORT (TM) -SP (SKIN PARALLEL) (Aug 25, 1987)
  • K871209 — NORFOLK MEDICAL NORPORT (Jun 24, 1987)
  • K871192 — SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT (Jun 10, 1987)
  • K870187 — NORFOLK NORPORT, SUBCUT. IMPLANTED DRUG DEL. DEPOT (May 7, 1987)
  • K870519 — SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT (Apr 15, 1987)

FDA data resources