Orthogonal Ep Catheters
FDA 510(k) K990958 · Irvine Biomedical, Inc.
510(k) numberK990958
Submission
- Device name
- Orthogonal Ep Catheters
- Applicant
- Irvine Biomedical, Inc.
Irvine, CA, US - Received
- March 22, 1999
- Decision date
- June 3, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K082061 | Inquiry H-Curve TV Steerable Diagnostic CatheterDRF · Special | 08/19/2008SE |
| K060757 | Inquiry Optima Plus Steerable Electrophysiology CatheterDRF · Special | 04/19/2006SE |
| K053582 | Inquiry Afocus II Diagnostic CatheterDRF · Special | 03/21/2006SE |
| K042775 | Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology CatheterDRF · Special | 11/04/2004SE |
| K010471 | Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569DRF · Special | 06/06/2001SE |
| K991878 | Luma-Cath Steerable Ep CathetersDRF · Traditional | 12/10/1999SE |
| K991025 | Luma-Cath Fixed Curve Ep CathetersDRF · Special | 10/15/1999SE |
| K982232 | Modification of the IBI-1100 Steerable Electrophysiology Catheter SystemDRF · Special | 07/25/1998SE |
| K961924 | IBI-1100 Steerable Electrophysiology Catheter SystemDRF · Traditional | 04/11/1997SE |
| K946333 | IBI-1000(TM) Electrophysiology CathterDRF · Traditional | 07/18/1995SE |
Questions and answers
When was Orthogonal Ep Catheters cleared by the FDA?
Orthogonal Ep Catheters (K990958) received a 510(k) decision of Substantially Equivalent on June 3, 1999, 73 days after the submission was received.
What is the product code of K990958?
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.