Cordis Webster Ref-Star Ex Surface Reference Device Model's D-1204-01, -02,-03, and -04.
FDA 510(k) K980961 · Cordis Webster, Inc.
510(k) numberK980961
Submission
- Device name
- Cordis Webster Ref-Star Ex Surface Reference Device Model's D-1204-01, -02,-03, and -04.
- Applicant
- Cordis Webster, Inc.
Baldwin Park, CA, US - Received
- March 16, 1998
- Decision date
- May 28, 1998
- 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
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| K233900 | Nordica PV Cryo Mapping CatheterDRF · Traditional | Synaptic Medical Corporation | 09/06/2024SE |
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| 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 |
| 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 |
| K953768 | Cordis Webster A20 Diagnostic Deflectable Tip CatheterDRF · Traditional | 11/22/1995SE |
Questions and answers
When was Cordis Webster Ref-Star Ex Surface Reference Device Model's D-1204-01, -02,-03, and -04. cleared by the FDA?
Cordis Webster Ref-Star Ex Surface Reference Device Model's D-1204-01, -02,-03, and -04. (K980961) received a 510(k) decision of Substantially Equivalent on May 28, 1998, 73 days after the submission was received.
What is the product code of K980961?
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.