DAP-PAK

FDA 510(k) clearance K781755 · decided 1979-02-15

Clearance details

K-number: K781755
Device name: DAP-PAK
Applicant: Dravon Medical, Inc.
Decision: Substantially Equivalent
Date received: 1978-10-17
Decision date: 1979-02-15
Days to decision: 121 days
Clearance type: Traditional
Product code: KDJ
Device class: 2
Regulation number: 876.5630
Medical specialty: Gastroenterology, Urology
Advisory committee: Gastroenterology, Urology
Location: Mchenry, IL, 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.

Record	Firm	Date
stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch (K250404)	Fresenius Medical Care Renal Therapies Group, LLC	2025-04-03
MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 (K231849)	Baxter Healthcare	2024-03-12
15L Cycler Drainage Bag (K214016)	Baxter Healthcare Corporation	2022-03-18
MiniCap Extended Life PD Transfer Sets (K192705)	Baxter Healthcare	2019-10-25
stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch (K173593)	Fresenius Medical Care Renal Therapies Group, LLC	2018-05-21
Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set (K173651)	Fresenius Medical Care Renal Therapies Group, LLC	2018-02-14
Cycler Drain Bag Set (K173363)	Fresenius Medical Care Renal Therapies Group, LLC	2018-01-24
Firefly Peritoneal Dialysis Connector Disinfection System (K151620)	Puracath Medical, Inc.	2016-01-20
FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution (K152129)	Baxter Healthcare Corporation	2015-10-29
EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER (K152675)	Baxter Healthcare	2015-10-29
APD LUER-LOCK ADAPTER (K124024)	Fresensius Medical Care North America	2013-09-19
FRESENIUS STERILE STAY SAFE CAP (K083542)	Fresenius Medical Care North America	2008-12-29

Recalls involving this device

No recalls on record reference this clearance.