Cordis Webster A20 Diagnostic Deflectable Tip Catheter
FDA 510(k) K953768 · Cordis Webster, Inc.
510(k) numberK953768
Submission
- Device name
- Cordis Webster A20 Diagnostic Deflectable Tip Catheter
- Applicant
- Cordis Webster, Inc.
Baldwin Park, CA, US - Received
- August 14, 1995
- Decision date
- November 22, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1220
- Specialty
- Cardiovascular
Other 510(k)s with product code DRF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252794 | Vision-MR Diagnostic CatheterDRF · Traditional | Imricor Medical Systems, Inc. | 01/08/2026SE |
| K250590 | MAGiC Sweep EP Mapping CatheterDRF · Traditional | Stereotaxis, Inc. | 07/23/2025SE |
| K250310 | VIKING Fixed Curve Diagnostic CatheterDRF · Traditional | Boston Scientific Corporation | 06/27/2025SE |
| K240366 | EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional…DRF · Traditional | Boston Scientific Corporation | 11/01/2024SE |
| K233900 | Nordica PV Cryo Mapping CatheterDRF · Traditional | Synaptic Medical Corporation | 09/06/2024SE |
| K233397 | Cosine-10TM Diagnostic CatheterDRF · Traditional | Medtronic, Inc. | 12/02/2023SE |
| K233207 | Polaris X Unidirectional Steerable Diagnostic CatheterDRF · Special | Boston Scientific Corporation | 10/27/2023SE |
| K232651 | BLAZER Dx-20 Bidirectional Steerable Diagnostic CatheterDRF · Special | Boston Scientific Corporation | 09/29/2023SE |
| K230503 | Polaris X Catheter Cable, Blazer Dx-20 Catheter CableDRF · Traditional | Boston Scientific | 04/25/2023SE |
| K210313 | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping CatheterDRF · Traditional | Shanghai Microport EP Medtech Co., Ltd. | 12/30/2022SE |
More from Shanghai Microport EP Medtech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K992965 | Cordis Webster Fixed Curve Catheters, Models D-1124, D-1085DRF · Traditional | 11/26/1999SE |
| K991531 | Cordis Webster Diagnostic Deflectable Tip Catheter, Model D-1078DRF · Traditional | 10/04/1999SE |
| K982740 | Cordis Webster Preface Braided Guiding Sheath & Perry Exchange Dilator, Model #'S…DYB · Special | 08/28/1998SE |
| K982415 | Cordis Webster Ref-Star External Reference Patch, Model # D-1210DRF · Special | 08/10/1998SE |
| K980961 | Cordis Webster Ref-Star Ex Surface Reference Device Model's D-1204-01, -02,-03, and -04.DRF · Traditional | 05/28/1998SE |
| K970264 | Cordis Webster Braided Guiding Sheath Exchange SystemDYB · Traditional | 10/28/1997SE |
| K953663 | Cordis Webster T20 Diagnostic Deflectable Tip CatheterDRF · Traditional | 09/18/1996SE |
| K955817 | Coridis Webster Deflectable Braided-Tip Electrode CatheterDRF · Traditional | 03/25/1996SE |
| K954390 | Cordis Wester Star CatheterDRF · Traditional | 12/21/1995SE |
Questions and answers
When was Cordis Webster A20 Diagnostic Deflectable Tip Catheter cleared by the FDA?
Cordis Webster A20 Diagnostic Deflectable Tip Catheter (K953768) received a 510(k) decision of Substantially Equivalent on November 22, 1995, 100 days after the submission was received.
What is the product code of K953768?
The FDA product code is DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording, a Class II (moderate risk) device regulated under 21 CFR 870.1220.