510(k) K002781
- Device
- MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORS
- Applicant
- MEDICAL CABLES, INC.
- 510(k) number
- K002781
- Product code
- DSA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-11-29
- Date received
- 2000-09-06
- Regulation
- 870.2900
- Classification name
- Cable, Transducer And Electrode, Patient, (including Connector)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRISTOPHER FONTANA
- Address
- 1340 Logan Ave. Costa Mesa CA US 92626 92626
FDA Registration Numbers#
- 1018233
- 3038181770
- 3004091615
- 3030308442
- 2011171
- 3013500228
- 3000126629
- 3012528160
- 3018258443
- 2134752
- 2182269
- 3002893037
- 3021691064
- 3019545235
- 1000121056
- 2939561
- 3013300026
- 1000122786
- 3012359877
- 2030624
- 1531159
- 3019388613
- 2024168
- 3017953522
- 3001762454
- 3012797688
- 3036754877
- 3027815
- 2124215
- 3014233600
- 2031044
- 3008603863
- 3003971136
- 9681860
- 3013426279
- 3008570547
- 3003687189
- 1450662
- 2936999
- 3009350690
- 1928237
- 3012179728
- 3013684844
- 1223925
- 3009485437
- 1319639
- 3020968442
- 3008963463
- 3009499478
- 3006634485
- 3014541700
- 3017178358
- 1313046
- 3009888765
- 3008363989
- 3016678045
- 9680933
- 3004415095
- 3010273872
- 9710602
- 3011713222
- 3003263092
- 3008483389
- 3014341624
- 3010703925
- 1320360
- 3009265194
- 3001104093
- 3010838917
- 3030733800
- 2182208
- 2017865
- 3006636961
- 1650347
- 3012659494
- 3005783425
- 3017636737
- 2135338
- 3017619000
- 1417592
Source Documents#
Other 510(k) Records For Product Code DSA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254114 | Baylis Connector Cable | Baylis Medical Technologies, Inc. | 2026-01-18 |
| K252827 | IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559) | Drägerwerk AG & Co. KGaA | 2025-12-01 |
| K251669 | IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter | Shanghai Draeger Medical Instrument Co., Ltd. | 2025-09-30 |
| K242986 | SpO2 Extension Cable | Beijing Rongrui-Century Science & Technology Co., Ltd. | 2025-05-02 |
| K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn | Philips Medizin Systeme Böblingen GmbH | 2025-01-17 |
| K240087 | RT Carbon ECG Leads | Ivy Biomedical Systems, Inc. | 2024-09-13 |
| K240377 | LIFEPAK® ECG Cables | Stryker Physio-Control | 2024-05-07 |
| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) | Physio-Control, Inc. | 2024-04-30 |
| K222712 | Fogg System Patient Monitoring Cables | Fogg System Company, Inc. | 2023-11-22 |
| K230571 | RFP-100A Connector Cable (Single Use) | Baylis Medical Technologies, Inc. | 2023-05-30 |
| K222370 | SpO2 Extension Cable | Beijing Rongrui-Century Science & Technology Co., Ltd. | 2023-04-02 |
| K220447 | Med-link Disposable ECG Cable and Leadwires | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2022-06-28 |
| K211941 | 9Line | Energetic Designs, Inc. | 2022-01-27 |
| K211294 | Multi-Link X2 ECG Cable and Leadwire System | Vyaire Medical, Inc. | 2021-08-16 |
| K203556 | Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables | Medtronic, Inc. | 2021-07-12 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases