Split Cath III 24CM Split Cath III 24CM Split Cath III 32CM Cath III 36CM Split Cath III 40CM and 55CM
FDA 510(k) K121848 · Medical Components, Inc.
510(k) numberK121848
Submission
- Device name
- Split Cath III 24CM Split Cath III 24CM Split Cath III 32CM Cath III 36CM Split Cath III 40CM and 55CM
- Applicant
- Medical Components, Inc.
Harleysville, PA, US - Received
- June 25, 2012
- Decision date
- September 21, 2012
- Decision
- Unknown (SESK)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MSD – Catheter, Hemodialysis, Implanted
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
- Life-sustaining
- Yes
Other 510(k)s with product code MSD
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|---|---|---|---|
| K241581 | Hemodialysis CatheterMSD · Traditional | Haolang Medical USA Corporation | 05/16/2025SESK |
| K210461 | End CapMSD · Traditional | Medical Components Inc (Medcomp) | 09/14/2021SE |
| K203575 | GlidePath Retro Long-Term Hemodialysis CatheterMSD · Traditional | C.R. Bard, Inc. | 07/01/2021SESK |
| K211410 | GlidePath 13F Long-Term Hemodialysis CatheterMSD · Special | Bard Peripheral Vascular, Inc. | 06/04/2021SESK |
| K203767 | Pristine Long-Term Hemodialysis CatheterMSD · Traditional | C B Bard, Inc. | 04/02/2021SESK |
| K202150 | GlidePath 7.5F Long-Term Dialysis CatheterMSD · Traditional | C.R. Bard, Inc. | 11/18/2020SESK |
| K202176 | Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMSD · Special | Medical Components, Inc. (dba MedComp) | 09/03/2020SE |
| K200627 | GlidePath 10F Long-Term Dialysis CatheterMSD · Traditional | C.R. Bard, Inc. | 06/22/2020SESK |
| K190527 | GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters…MSD · Traditional | C. R. Bard | 03/05/2020SESK |
| K182443 | Pristine Hemodialysis CatheterMSD · Traditional | Pristine Access Technologies , Ltd. | 05/31/2019SE |
More from Pristine Access Technologies , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K250836 | 14F Duo-Flow® Side X Side Double Lumen CatheterMPB · Traditional | 08/12/2025SE |
| K141633 | Pro-Picc with Valve TechnologyLJS · Traditional | 09/29/2014SE |
| K132880 | Medcomp Power Injectable Safety Huber NeedleFPA · Traditional | 01/08/2014SE |
| K131687 | 6F X 60CM Triple Pro-Line CT Basic Ir SetLJS · Traditional | 08/16/2013SE |
| K130687 | 2F & 3F Vascu-Sheath Tearaway IntroducerDYB · Traditional | 08/15/2013SE |
| K130923 | 5F Dignity CT Titanium PortLJT · Traditional | 07/31/2013SE |
| K124046 | Valved Tearaway Introducer Generation IIDYB · Traditional | 06/03/2013SE |
| K123617 | 3F Pro-PiccLJS · Traditional | 05/15/2013SE |
| K122423 | Vasu-PiccLJS · Traditional | 12/12/2012SE |
| K120281 | Dignity Power Injectable Titanium PortLJT · Traditional | 09/17/2012SE |
Questions and answers
When was Split Cath III 24CM Split Cath III 24CM Split Cath III 32CM Cath III 36CM Split Cath III 40CM and 55CM cleared by the FDA?
Split Cath III 24CM Split Cath III 24CM Split Cath III 32CM Cath III 36CM Split Cath III 40CM and 55CM (K121848) received a 510(k) decision of Unknown on September 21, 2012, 88 days after the submission was received.
What is the product code of K121848?
The FDA product code is MSD – Catheter, Hemodialysis, Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.