Atlas FDA

TPN TRAY (STERILE)

FDA 510(k) clearance K925021 · decided 1993-06-07

Clearance details

K-number
K925021
Device name
TPN TRAY (STERILE)
Applicant
Customed, Inc.
Decision
Unknown
Date received
1992-09-24
Decision date
1993-06-07
Days to decision
256 days
Clearance type
Traditional
Product code
MCY
Device class
2
Regulation number
880.5075
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Fajardo, PR, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM (K970721)Johnson & Johnson Medical, Inc.1997-03-21
CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY (K963719)Grand Medical Products1996-11-27
WOUND CARE COMPRESSION SYSTEM (WCCS) (K960585)Suncoast Medical Products, Inc.1996-04-26
DRESSING CHANGE TRAY (K952334)Busse Hospital Disposables, Inc.1995-07-14
CIRCULON SYSTEM STEP 1 (K951022)Convatec, A Division of E.R. Squibb & Sons1995-06-12
CIRCULON SYSTEM STEP 2 (K951021)Convatec, A Division of E.R. Squibb & Sons1995-06-12
E-PACK PROCEDURE KITS (K951476)ETHICON, Inc.1995-05-23
DRESSING CHANGE TRAY-MODIFIED (K931932)Medsurg Industries, Inc.1993-08-27
VARIOUS NON-STERILE CUSTOM TRAYS/KITS (K924690)Surgipro Central, Inc.1993-07-16
WOUND DRESSING KIT (K923905)Kit Pak, Inc.1993-07-02
PER-Q-CATH DRESSING CHANGE TRAY (K926063)Gesco Intl., Inc.1993-06-07
CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER (K921347)Medi-Flex Hospital Products, Inc.1993-01-08

Recalls involving this device

RecordFirmDate
DRESSING CHANGE CUSTOMED 50/CS Used by medical staff to perform surgical procedures and pa recall (Z-2593-2015)Customed, Inc2015-09-03