Introducing Catheter
FDA 510(k) K883933 · Devices For Vascular Intervention, Inc.
510(k) numberK883933
Submission
- Device name
- Introducing Catheter
- Applicant
- Devices For Vascular Intervention, Inc.
Redwood City, CA, US - Received
- September 15, 1988
- Decision date
- December 2, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
Other 510(k)s with product code DYB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253526 | NAMIC Dilator and SheathDYB · Traditional | Medline Industries, LP | 07/29/2026SE |
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…DYB · Traditional | Hartman Medical Group, LLC | 07/06/2026SE |
| K261242 | SimplGuideDYB · Traditional | Pendracare | 06/25/2026SE |
| K261950 | Health Line Tearaway IntroducerDYB · Traditional | Health Line International Corporation | 06/22/2026SE |
| K261492 | FieldFlex Steerable SheathDYB · Special | CenterPoint Systems, LLC | 06/05/2026SE |
| K260606 | Echo Large Bore Introducer SheathDYB · Traditional | Echo Medical, LLC | 04/29/2026SE |
| K254248 | Introducer Sheath SetDYB · Traditional | Cardiocycle Medical(Suzhou) Co., Ltd. | 04/23/2026SE |
| K254279 | Edwards eSheath+ introducer setDYB · Traditional | Edwards Lifesciences | 04/17/2026SE |
| K260091 | Aventus Introducer SheathDYB · Traditional | Inquis Medical | 04/13/2026SE |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001)DYB · Traditional | Protaryx Medical, Inc. | 04/10/2026SE |
More from Protaryx Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K935929 | MicrotrackMCW · Traditional | 03/10/1994SE |
| K920707 | Hollow Motor Drive Unit W/ Torque ControllerMCW · Traditional | 11/23/1992SE |
| K914422 | Devices for Vascu Intervent Rotat Hemostat ValveDQY · Traditional | 12/18/1991SE |
| K911678 | Rotating Hemostatic ValveDYB · Traditional | 07/12/1991SE |
| K910205 | LP-60 Low Pressure Inflation DeviceMAV · Traditional | 02/25/1991SE |
| K901601 | Hollow Motor Drive UnitLIT · Traditional | 07/06/1990SE |
| K883981 | Guiding Catheter (Tip Softness Change)DWF · Traditional | 11/03/1988SE |
| K883916 | Rotating Hemostatic ValveDQY · Traditional | 10/28/1988SE |
| K883346 | Simpson Peripheral Atherocath W/Addit. Size 13FLIT · Traditional | 09/26/1988SE |
| K881088 | Addition of a Tip Guard to the Atherocath(Tm)LIT · Traditional | 05/31/1988SE |
Questions and answers
When was Introducing Catheter cleared by the FDA?
Introducing Catheter (K883933) received a 510(k) decision of Substantially Equivalent on December 2, 1988, 78 days after the submission was received.
What is the product code of K883933?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.