Pediatric Multi-Function Electrodes
FDA 510(k) K915159 · Zmi Corp.
510(k) numberK915159
Submission
- Device name
- Pediatric Multi-Function Electrodes
- Applicant
- Zmi Corp.
Woburn, MA, US - Received
- November 14, 1991
- Decision date
- February 7, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K250310 | VIKING Fixed Curve Diagnostic CatheterDRF · Traditional | Boston Scientific Corporation | 06/27/2025SE |
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| 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 |
|---|---|---|
| K915100 | Brindley & Smith ET-1000LIH · Traditional | 09/14/1992SE |
| K913484 | Zoll D-900 DefibrillatorLDD · Traditional | 12/16/1991SE |
| K911956 | Zoll PD-1400 Pacer/DefibrillatorDRO · Traditional | 07/31/1991SE |
| K895032 | Zoll PD 2200 Pacing-Defibrillation ElectrodesLDD · Traditional | 10/12/1989SE |
| K885166 | Zmi Part No. NTP-2100, Pediatric ElectrodesDRO · Traditional | 05/01/1989SE |
| K873402 | Zoll NTP-1200 Pacer/DefibrillatorDRO · Traditional | 11/23/1987SE |
| K855015 | Noninvasive Temp. Pacemaker NTP-1000DRO · Traditional | 03/31/1986SE |
Questions and answers
When was Pediatric Multi-Function Electrodes cleared by the FDA?
Pediatric Multi-Function Electrodes (K915159) received a 510(k) decision of Substantially Equivalent on February 7, 1992, 85 days after the submission was received.
What is the product code of K915159?
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.