510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K930206Unknown

Ps Medical Ipi Access Kit

Pudenz-Schulte Medical Research Corp., Goleta CA / Traditional, Unknown
FDA source (opens on fda.gov)

K930206 is the FDA 510(k) clearance record for PS MEDICAL IPI ACCESS KIT, a class II device, cleared for Pudenz-Schulte Medical Research Corp. on under FDA product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular). FDA records list 40 510(k) clearances for Pudenz-Schulte Medical Research Corp., from to . As of , FDA records show no recalls naming K930206.

Clearance record

Decision date
Received
(406 days to decision)
Product code
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Regulation
21 CFR 880.5965
Device class
Class II
Review panel
General Hospital
Applicant
Pudenz-Schulte Medical Research Corp. 125-B Cremona Dr., Goleta CA
510(k) summary
Summary
Third party review
No

Clearances, product code LJT

Trailing 12 months
1 clearance under product code LJT in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LJT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260