510(k) K915304
- Device
- Abbott Smart Cap
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K915304
- Product code
- KDJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-02-19
- Date received
- 1991-11-21
- Regulation
- 876.5630
- Classification name
- Set, Administration, For Peritoneal Dialysis, Disposable
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- FREDERICK GUSTAFSON
- Address
- One Abbott Park Rd. Abbott Park IL US 60064 60064
FDA Registration Numbers#
- 1058584
- 3038277270
- 3001239013
- 3032828299
- 9611823
- 3013188547
- 3038195011
- 1225714
- 2314912
- 1649518
- 3003504604
- 3035708507
- 9680579
- 3002907620
- 3016096143
- 1019003
- 3004111573
- 1650907
- 8030639
- 3005941719
- 3015335038
- 3039353681
- 9612168
- 8030665
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KDJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250404 | 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 | Fresenius Medical Care Renal Therapies Group, LLC | 2025-04-03 |
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 | Baxter Healthcare | 2024-03-12 |
| K214016 | 15L Cycler Drainage Bag | Baxter Healthcare Corporation | 2022-03-18 |
| K192705 | MiniCap Extended Life PD Transfer Sets | Baxter Healthcare | 2019-10-25 |
| K173593 | 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 | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-21 |
| K173651 | Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set | Fresenius Medical Care Renal Therapies Group, LLC | 2018-02-14 |
| K173363 | Cycler Drain Bag Set | Fresenius Medical Care Renal Therapies Group, LLC | 2018-01-24 |
| K151620 | Firefly Peritoneal Dialysis Connector Disinfection System | Puracath Medical, Inc. | 2016-01-20 |
| K152129 | FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution | Baxter Healthcare Corporation | 2015-10-29 |
| K152675 | EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER | Baxter Healthcare | 2015-10-29 |
| K124024 | APD LUER-LOCK ADAPTER | Fresensius Medical Care North America | 2013-09-19 |
| K083542 | FRESENIUS STERILE STAY SAFE CAP | Fresenius Medical Care North America | 2008-12-29 |
| K042900 | K.E.P. CONNECTOR AND CLIP | K.E.P., LLC | 2004-11-05 |
| K041792 | FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211 | Fresenius Medical Care North America | 2004-09-24 |
| K031676 | HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q | Baxter Healthcare Corp | 2003-11-20 |