Diatek Connector Assembly Replacement Kit (Cark)
FDA 510(k) K020430 · Diatek, Inc.
510(k) numberK020430
Submission
- Device name
- Diatek Connector Assembly Replacement Kit (Cark)
- Applicant
- Diatek, Inc.
Winston-Salem, NC, US - Received
- February 8, 2002
- Decision date
- May 9, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NFK – Kit, Repair, Catheter, Hemodialysis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Hemodialysis Tray
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K101261 | Catheter Repair Kit with Replacement Connector, Model 5587000NFK · Traditional | C.R. Bard, Inc. | 07/29/2010SE |
| K092797 | Acute and Chronic Catheter Repair KitNFK · Traditional | Kendall | 11/19/2009SESK |
| K063446 | Catheter Repair Kit with Replacement Connector, Model 5587000NFK · Special | C.R. Bard, Inc. | 12/15/2006SE |
| K062435 | Repair Kit for Xpresso, Decathlon, and Alta LR CathetersNFK · Traditional | Spire Biomedical, Inc. | 12/05/2006SE |
| K030442 | Catheter Repair Kit with Replacement Connector, Model 5587000NFK · Traditional | C.R. Bard, Inc. | 07/21/2003SE |
| K022644 | Retro Repair Kit, Model PRRK5NFK · Traditional | Spire Biomedical, Inc. | 11/06/2002SESK |
| K022570 | Medcomp Repair Kit, Model AspcrpkNFK · Traditional | Medcomp | 10/31/2002SE |
| K022561 | Catheter Repair Kit with Replacement Connector, Model 5587000NFK · Traditional | C.R. Bard, Inc. | 08/23/2002SE |
| K011015 | Catheter Repair Kit with Replacement Connector, Model 5587000NFK · Traditional | C.R. Bard, Inc. | 06/22/2001SE |
| K011576 | Medcomp Ash SplitNFK · Special | Medical Components, Inc. | 06/21/2001SE |
More from Medical Components, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K010399 | Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC…MSD · Traditional | 08/14/2001SE |
| K895703 | Diatek Model 700 ThermometerFLL · Traditional | 12/07/1989SE |
| K872178 | Modification to Arkive(Tm)BSZ · Traditional | 01/27/1988SE |
| K862085 | Arkive (TM)BSZ · Traditional | 01/12/1987SE |
| K841827 | Enteroport Nutrition PumpFRN · Traditional | 07/27/1984SE |
| K841859 | Secura SetFPA · Traditional | 07/03/1984SE |
| K833568 | Diatek 600 Thermometer SystemFLL · Traditional | 01/10/1984SE |
| K830565 | Secura Set Secondary Admin. SetFPA · Traditional | 03/09/1983SE |
| K830377 | Secura Set Primary Admin. SetFPA · Traditional | 03/01/1983SE |
| K830355 | Secura IV Volumetric Infusion PumpFRN · Traditional | 03/01/1983SE |
Questions and answers
When was Diatek Connector Assembly Replacement Kit (Cark) cleared by the FDA?
Diatek Connector Assembly Replacement Kit (Cark) (K020430) received a 510(k) decision of Substantially Equivalent on May 9, 2002, 90 days after the submission was received.
What is the product code of K020430?
The FDA product code is NFK – Kit, Repair, Catheter, Hemodialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5540.