Model DMC-75 Mini-Catheter Set
FDA 510(k) K874307 · Life-Tech Intl., Inc.
510(k) numberK874307
Submission
- Device name
- Model DMC-75 Mini-Catheter Set
- Applicant
- Life-Tech Intl., Inc.
Houston, TX, US - Received
- October 20, 1987
- Decision date
- January 29, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K250325 | BD Alaris Pump Infusion SetFPA · Traditional | Carefusion (Bd) | 10/30/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
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| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 07/24/2025SE |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K001129 | Prolong, Models PL50, PL100, PL150CAZ · Traditional | 07/06/2000SE |
| K955031 | MaxistimKOI · Traditional | 12/10/1996SE |
| K954505 | Ez StimKOI · Traditional | 12/10/1996SE |
| K954315 | PVC Abdominal/Rectal Pressure CatheterFEN · Traditional | 11/30/1995SE |
| K954341 | Urodynamics Tubing and Infusion SetsFEN · Traditional | 10/17/1995SE |
| K953451 | Uropump Tube & Damping ChamgerFEN · Traditional | 10/05/1995SE |
| K953353 | Urovision JanusFEN · Traditional | 09/08/1995SE |
| K946108 | Ear-A-GatorKHH · Traditional | 06/13/1995SE |
| K913601 | MicrophorEGJ · Traditional | 07/15/1994SE |
| K940203 | Triple Lumen Urodynamic Catheter with Radiopaque MarkersFEN · Traditional | 03/30/1994SE |
Questions and answers
When was Model DMC-75 Mini-Catheter Set cleared by the FDA?
Model DMC-75 Mini-Catheter Set (K874307) received a 510(k) decision of Substantially Equivalent on January 29, 1988, 101 days after the submission was received.
What is the product code of K874307?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.