Medcomp Repair Kit, Model Aspcrpk
FDA 510(k) K022570 · Medcomp
510(k) numberK022570
Submission
- Device name
- Medcomp Repair Kit, Model Aspcrpk
- Applicant
- Medcomp
Harleysville, PA, US - Received
- August 2, 2002
- Decision date
- October 31, 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
Other 510(k)s with product code NFK
| 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 |
| K022561 | Catheter Repair Kit with Replacement Connector, Model 5587000NFK · Traditional | C.R. Bard, Inc. | 08/23/2002SE |
| K020430 | Diatek Connector Assembly Replacement Kit (Cark)NFK · Traditional | Diatek, Inc. | 05/09/2002SE |
| 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 |
|---|---|---|
| K130889 | Split Cath RGMSD · Traditional | 04/28/2014SESK |
| K123292 | T3NIE · Traditional | 06/11/2013SE |
| K102966 | 2.6F X 20CM Vascu-Picc, 2.6F X 50CM Vascu-PiccLJS · Traditional | 12/21/2010SE |
| K091954 | Micro-Stick SetDYB · Traditional | 01/08/2010SE |
| K092347 | Pro-Picc CTLJS · Special | 09/16/2009SE |
| K091953 | Pro-PiccLJS · Traditional | 09/16/2009SE |
| K090394 | Valved Tearway IntroducerDYB · Traditional | 09/01/2009SE |
| K091586 | Vascu-Picc and Midline Catheters, Single, Double and Triple LumenLJS · Traditional | 07/23/2009SE |
| K091466 | 1.9F X 20CM Vascu-Picc, 1.9F X 50CM Vascu-Picc, Model VPI.9S20, VPI.9S50LJS · Special | 06/17/2009SE |
| K081775 | The Medcomp .010 Vascular GuidewiresDQX · Traditional | 03/25/2009SE |
Questions and answers
When was Medcomp Repair Kit, Model Aspcrpk cleared by the FDA?
Medcomp Repair Kit, Model Aspcrpk (K022570) received a 510(k) decision of Substantially Equivalent on October 31, 2002, 90 days after the submission was received.
What is the product code of K022570?
The FDA product code is NFK – Kit, Repair, Catheter, Hemodialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5540.