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510(k) K911382

IPI ALGO-LINE CATHETER by Pudenz-Schulte Medical Research Corp. — Product Code MAJ

K911382 is an FDA 510(k) premarket notification submitted by Pudenz-Schulte Medical Research Corp. for the device "IPI ALGO-LINE CATHETER". The FDA issued a decision of Substantially Equivalent on July 18, 1991. The device falls under product code MAJ (Catheter, Percutaneous, Intraspinal, Short Term), a Class II device regulated under 21 CFR 868.5120. Pudenz-Schulte Medical Research Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1991
Date Received
March 28, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous, Intraspinal, Short Term
Device Class
Class II
Regulation Number
868.5120
Review Panel
HO
Submission Type

Other clearances by Pudenz-Schulte Medical Research Corp.

  • K960055 — MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 893 (September 30, 1996)
  • K954409 — PS MEDICAL IPI VASCULAR ACCESS CATHETER (December 18, 1995)
  • K951258 — PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT (September 18, 1995)
  • K934167 — IPI DUAL LUMEN PORT (July 14, 1994)
  • K934796 — IPI LOW PROFILE IMPORT (July 14, 1994)
  • K940096 — PS MEDICAL CATHETER PLACEMENT KIT (May 3, 1994)
  • K934545 — PS MEDICAL DELTA BURR HOLE VALVE (April 28, 1994)
  • K930206 — PS MEDICAL IPI ACCESS KIT (February 25, 1994)
  • K930606 — PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER (September 10, 1993)
  • K913412 — PS MEDICAL CSF-ACCESS DEVICE (March 30, 1993)

Other clearances for product code MAJ

  • K965251 — MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM (March 18, 1997)
  • K945413 — MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT (May 24, 1995)
  • K934939 — TEMPORARY SCREENING LEAD/ CATHETER KIT (May 24, 1995)
  • K930218 — SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES (July 27, 1993)
  • K893766 — LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE (November 1, 1989)

FDA data resources