Modified Schneider-Shiley Flushing Catheter
FDA 510(k) K875326 · Schneider-Shilley (Usa)
510(k) numberK875326
Submission
- Device name
- Modified Schneider-Shiley Flushing Catheter
- Applicant
- Schneider-Shilley (Usa)
Minneapolis, MN, US - Received
- December 29, 1987
- Decision date
- February 18, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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| K254278 | Arterial Pressure Monitoring Set/TrayDQO · Special | Spectrum Vascular | 03/25/2026SE |
| K250751 | DualView CatheterDQO · Traditional | Terumo Corporation | 07/17/2025SE |
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| K242420 | pNOVUS 21 MicrocatheterDQO · Traditional | Phenox, Ltd. | 11/12/2024SE |
| K233268 | Impress Angiographic CatheterDQO · Special | Merit Medical Systems, Inc. | 05/22/2024SE |
| K233975 | Zoom 6F Insert CathetersDQO · Traditional | Imperative Care, Inc. | 04/02/2024SE |
| K232536 | Soldier MicrocatheterDQO · Traditional | Embolx, Inc. | 02/23/2024SE |
| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
More from Cordis US Corp
| 510(k) | Device | Decision |
|---|---|---|
| K882826 | Softrac-Pta Peripheral Dilatation CatheterLIT · Traditional | 01/24/1989SE |
| K875175 | Modified Peripheral Dilatation CathetersLIT · Traditional | 07/28/1988SE |
| K881197 | Softrac-Pta(Tm) Peripheral Dilatation CatheterLIT · Traditional | 05/16/1988SE |
| K875323 | Modified Schneider-Shiley Wire TorquerDQX · Traditional | 03/28/1988SE |
| K875322 | Modified Schneider-Shiley Pressure ManometerKRK · Traditional | 03/28/1988SE |
| K875327 | Modified Seldinger Initial Puncture InstrumentDRE · Traditional | 03/25/1988SE |
| K875324 | Modified Schneider Shiley Inflation SyringesDXT · Traditional | 03/25/1988SE |
| K875325 | Modified Occluder/Flushing Catheter StopcockDQO · Traditional | 02/18/1988SE |
Questions and answers
When was Modified Schneider-Shiley Flushing Catheter cleared by the FDA?
Modified Schneider-Shiley Flushing Catheter (K875326) received a 510(k) decision of Substantially Equivalent on February 18, 1988, 51 days after the submission was received.
What is the product code of K875326?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.