Dual Lumen L-Cath Catheter System
FDA 510(k) K925979 · Luther Medical Products, Inc.
510(k) numberK925979
Submission
- Device name
- Dual Lumen L-Cath Catheter System
- Applicant
- Luther Medical Products, Inc.
Tustin, CA, US - Received
- November 25, 1992
- Decision date
- May 27, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide WireDQX · Special | Merit Medical Ireland , Ltd. | 07/13/2026SE |
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| K253262 | EmeryGlide (EG18008901)DQX · Special | Nano4imaging GmbH | 03/06/2026SE |
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| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire…DQX · Traditional | Merit Medical Ireland, Ltd. | 01/21/2026SE |
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More from Solo Pace, Inc.
| 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 |
| K940198 | L-Cath Connector AssemblyGCD · Traditional | 12/15/1994SE |
| 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 |
| K924968 | L-Cath Peel-Away Catheter SystemFOZ · Traditional | 05/21/1993SE |
| K924562 | Catheter IntroducerDYB · Traditional | 02/25/1993SE |
Questions and answers
When was Dual Lumen L-Cath Catheter System cleared by the FDA?
Dual Lumen L-Cath Catheter System (K925979) received a 510(k) decision of Substantially Equivalent on May 27, 1993, 183 days after the submission was received.
What is the product code of K925979?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.