Franz Catheter
FDA 510(k) K881853 · Ep Technologies, Inc.
510(k) numberK881853
Submission
- Device name
- Franz Catheter
- Applicant
- Ep Technologies, Inc.
Mountain View, CA, US - Received
- May 3, 1988
- Decision date
- July 18, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K043257 | Real-Time Position Management (RPM) SystemDRF · Special | 02/03/2005SE |
| K013349 | Astronomer Plus SystemDQK · Abbreviated | 04/09/2002SE |
| K003452 | Polaris X Catheters, Model 7000D,7001D,7003D,7004D,7005D,7006DDRF · Special | 12/07/2000SE |
| K940167 | Diagnostic I CatheterDRF · Traditional | 08/02/1994SE |
| K940168 | Diagnostic II CatheterDRF · Traditional | 07/27/1994SE |
| K924109 | Steerocath IIDRF · Traditional | 12/16/1993SE |
| K924108 | Tracfinder IIDRF · Traditional | 12/16/1993SE |
| K913375 | Torque Tube Steerocath(Tm)DRF · Traditional | 10/25/1991SE |
| K903880 | Franz(Tm) Steerable Combination CatheterDRF · Traditional | 10/12/1990SE |
| K900765 | Steerocath(Tm)DRF · Traditional | 05/07/1990SE |
Questions and answers
When was Franz Catheter cleared by the FDA?
Franz Catheter (K881853) received a 510(k) decision of Substantially Equivalent on July 18, 1988, 76 days after the submission was received.
What is the product code of K881853?
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.