CEPTI-SEAL I.V. PREP KIT— 510(k) K930196

Clearance details

Applicant

Medi-Flex Hospital Products, Inc.

Product code

Code LRS

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

1993-01-14

Decision date

1993-07-02

Decision

Unknown

Clearance type

Traditional

Location

Overland Park, KS, US

• K050654 — AMSINO I.V. START KIT2005-05-02
• K001879 — INFUSION IV SET2001-11-20
• K963722 — IV START KIT1996-11-27
• K951167 — EMS I.V. START KIT1995-05-16
• K950184 — B. BRAUN IV START KITS1995-03-15

• K970441 — K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH1997-05-09
• K962740 — DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/2606411996-09-06
• K952201 — PORT-A-CATH ACCESS KIT1995-10-04
• K952416 — TRACHEOSTOMY CARE KIT1995-08-09
• K952256 — PICC LINE KIT1995-07-31

Other

2

Total

2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →