L-Cath Connector Assembly
FDA 510(k) K940198 · Luther Medical Products, Inc.
510(k) numberK940198
Submission
- Device name
- L-Cath Connector Assembly
- Applicant
- Luther Medical Products, Inc.
Tustin, CA, US - Received
- January 13, 1994
- Decision date
- December 15, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCD – Connector, Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GCD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952470 | Acti-Flex Low, Medium, Rescare I, Rescare Ii.GCD · Traditional | R-Group Intl. | 11/28/1995SE |
| K863446 | Angiomed High Pressure ConnectorsGCD · Traditional | Angiomed U.S., Inc. | 09/23/1986SE |
| K851196 | Incision DrainGCD · Traditional | Sil-Med Corp. | 06/04/1985SE |
| K851921 | Y ConnectorGCD · Traditional | Sil-Med Corp. | 05/17/1985SE |
| K760524 | Catheter Connector, Argyle TubingGCD · Traditional | Sherwood Medical Industries | 11/02/1976SE |
| K760382 | ConnectorsGCD · Traditional | B. Braun Instruments | 11/02/1976SE |
| K760203 | Tube, Sterile Non-Conductive ConnectingGCD · Traditional | Ipco Corp. | 07/19/1976SE |
More from Ipco Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K982797 | Blunt T-Peel Introducer Model Number PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICBDYB · Traditional | 11/30/1998SE |
| K980090 | Onecath, L-Cath Catheter System, Model OC-(16-22 Ga., 5CM-60CM)LJS · Traditional | 03/24/1998SE |
| K974543 | L-Cath Modified Seldinger Technique Insertion/Catheter Exchange Kit PE-MST24-24 Ga. Kit…FOZ · Traditional | 02/10/1998SE |
| K942103 | L-Cath Catheter System - Port L-CathLJT · Traditional | 07/26/1994SE |
| K930473 | Onecath L-Cath Catheter SystemLJS · Traditional | 04/07/1994SEKD |
| K925236 | L Cath(R) Catheter SystemLJS · Traditional | 03/22/1994SE |
| K920755 | L-Cath Peel Away System CatheterLJS · Traditional | 06/07/1993SE |
| K925979 | Dual Lumen L-Cath Catheter SystemDQX · Traditional | 05/27/1993SE |
| K924968 | L-Cath Peel-Away Catheter SystemFOZ · Traditional | 05/21/1993SE |
| K924562 | Catheter IntroducerDYB · Traditional | 02/25/1993SE |
Questions and answers
When was L-Cath Connector Assembly cleared by the FDA?
L-Cath Connector Assembly (K940198) received a 510(k) decision of Substantially Equivalent on December 15, 1994, 336 days after the submission was received.
What is the product code of K940198?
The FDA product code is GCD – Connector, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.