Adaptaid Temp. Pacing Ext. Lead #366-02
FDA 510(k) K820268 · Intermedics, Inc.
510(k) numberK820268
Submission
- Device name
- Adaptaid Temp. Pacing Ext. Lead #366-02
- Applicant
- Intermedics, Inc.
Mchenry, IL, US - Received
- February 2, 1982
- Decision date
- March 26, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSA – Cable, Transducer And Electrode, Patient, (Including Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2900
- Specialty
- Cardiovascular
Other 510(k)s with product code DSA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254114 | Baylis Connector CableDSA · Special | Baylis Medical Technologies, Inc. | 01/18/2026SE |
| K252827 | IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott…DSA · Traditional | Drägerwerk AG & Co. KGaA | 12/01/2025SE |
| K251669 | IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger…DSA · Traditional | Shanghai Draeger Medical Instrument Co., Ltd. | 09/30/2025SE |
| K242986 | SpO2 Extension CableDSA · Special | Beijing Rongrui-Century Science & Technology… | 05/02/2025SE |
| K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171…DSA · Traditional | Philips Medizin Systeme Böblingen GmbH | 01/17/2025SE |
| K240087 | RT Carbon ECG LeadsDSA · Traditional | Ivy Biomedical Systems, Inc. | 09/13/2024SE |
| K240377 | LIFEPAK® ECG CablesDSA · Traditional | Stryker Physio-Control | 05/07/2024SE |
| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…DSA · Traditional | Physio-Control, Inc. | 04/30/2024SE |
| K222712 | Fogg System Patient Monitoring CablesDSA · Traditional | Fogg System Company, Inc. | 11/22/2023SE |
| K230571 | RFP-100A Connector Cable (Single Use)DSA · Traditional | Baylis Medical Technologies, Inc. | 05/30/2023SE |
More from Baylis Medical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954610 | Model 430-07 Endocardial Pacing LeadDTB · Traditional | 12/16/1996PT |
| K955122 | Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable Endocardial Pacing…DTB · Traditional | 11/04/1996ST |
| K962174 | Biplr Im En Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07)DTB · Traditional | 08/21/1996ST |
| K955550 | Cardifix Ez Bipolar/Unipolar Endocardial Pacing LeadDTB · Traditional | 06/19/1996ST |
| K960281 | Implantable Pacing Leads/Implantable Accessory/Non-Implantable AccessoryDTB · Traditional | 06/18/1996ST |
| K954719 | Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing LeadDTB · Traditional | 02/27/1996ST |
| K933278 | Intermedics Triangle Chest Probe Model 526-04KRG · Traditional | 03/15/1995SE |
| K922042 | Cardifix Endocardial Pacing LeadDTB · Traditional | 04/29/1993SESP |
| K922972 | Models 438-05 and 435-05 Implantable Pacing LeadDTB · Traditional | 01/22/1993SESP |
| K920530 | Intermedics Model 366-15 VS 1 Header PlugDXY · Traditional | 03/17/1992SE |
Questions and answers
When was Adaptaid Temp. Pacing Ext. Lead #366-02 cleared by the FDA?
Adaptaid Temp. Pacing Ext. Lead #366-02 (K820268) received a 510(k) decision of Substantially Equivalent on March 26, 1982, 52 days after the submission was received.
What is the product code of K820268?
The FDA product code is DSA – Cable, Transducer And Electrode, Patient, (Including Connector), a Class II (moderate risk) device regulated under 21 CFR 870.2900.