SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER
FDA 510(k) clearance K926003 · decided 1993-06-07
Clearance details
- K-number
- K926003
- Device name
- SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER
- Applicant
- Schneider Intl., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1992-11-27
- Decision date
- 1993-06-07
- Days to decision
- 192 days
- Clearance type
- Traditional
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
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| Arterial Pressure Monitoring Set/Tray (K254278) | Spectrum Vascular | 2026-03-25 |
| DualView Catheter (K250751) | Terumo Corporation | 2025-07-17 |
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| pNOVUS 21 Microcatheter (K242420) | Phenox, Ltd. | 2024-11-12 |
| Impress Angiographic Catheter (K233268) | Merit Medical Systems, Inc. | 2024-05-22 |
| Zoom 6F Insert Catheters (K233975) | Imperative Care, Inc. | 2024-04-02 |
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| INFINITI™ Ambi Angiographic Catheter (K232573) | Cordis US Corp | 2023-11-21 |
| Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (K230620) | Gentuity, LLC | 2023-08-08 |
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Recalls involving this device
No recalls on record reference this clearance.