Product Code: OTK


Products Classified as OTK

5825Wound Drain Catheter SystemPowered Suction Pump.

Total Product Life Cycle (TPLC) Devices

5825Wound Drain Catheter SystemPowered Suction Pump.

FDA Consensus Standards

Wound Drain Catheter System [36728]21 CFR §878.4780 🔎
Wound Drain Catheter System [36708]21 CFR §878.4780 🔎

Pre-market Notifications for OTK

K191733The ZIP Accessory Shuttle For PleuraFlow SystemClearFlow, Inc.
K182067PleuraFlow System With FlowGlide Extra Drainage LengthClearFlow, Inc.
K163139PleuraFlow System With FlowGlideCLEARFLOW, INC.
K153681PleuraFlow SystemCLEARFLOW, INC.
K150042PleuraFlow SystemClearFlow, Inc.
K093565PLEURAFLOW CATHETER SYSTEMCLEAR CATHETER SYSTEMS

Global Unique Device Identification Database

20856449006103Wound Drain Catheter System
00856449006093Wound Drain Catheter System
20856449006080Wound Drain Catheter System
20856449006073Wound Drain Catheter System
20856449006066Wound Drain Catheter System
20856449006059Wound Drain Catheter System
00856449006031Wound Drain Catheter System
10856449006021Wound Drain Catheter System
20856449006011Wound Drain Catheter System
00856449006000Wound Drain Catheter System
20856449006127Wound Drain Catheter System
00856449006147Wound Drain Catheter System
20856449006110Wound Drain Catheter System
00856449006161Wound Drain Catheter System
10856449006267Wound Drain Catheter System

Maude Adverse Events

PLEURAFLOW SYSTEM WITH FLOWGLIDECLEARFLOW INC2019-08-08
PLEURAFLOW SYSTEMCLEARFLOW, INC2017-09-22
PLEURAFLOW SYSTEM WITH FLOWGLIDECLEARFLOW, INC.2017-06-06
PLEURAFLOW SYSTEMCLEARFLOW, INC.2017-03-09
PLEURAFLOW SYSTEMCLEARFLOW, INC.2017-03-01
PLEURAFLOW SYSTEMCLEARFLOW, INC.2017-03-01
PLEURAFLOW SYSTEMCLEARFLOW, INC.2017-03-01
JACKSON-PRATT SILICONE FLAT DRAIN 10MMX20CMCARDINAL HEALTH 200 LLC2016-08-29
JACKSON PRATT DRAINUNKNOWN2016-08-23
PLEURAFLOW SYSTEMCLEARFLOW, INC.2016-06-07
PLEURAFLOW SYSTEMCLEARFLOW, INC.2015-11-13
PLEURAFLOW SYSTEMCLEARFLOW INC2015-09-09
PLEURAFLOW SYSTEMCLEARFLOW INC2015-08-10
PLEURAFLOW SYS, 20FRXERIDIEM2013-11-06
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