Safe Connect Surgical Cable (S-101-97/S-201-97/FL-601-97)
FDA 510(k) K971968 · Remington Medical, Inc.
510(k) numberK971968
Submission
- Device name
- Safe Connect Surgical Cable (S-101-97/S-201-97/FL-601-97)
- Applicant
- Remington Medical, Inc.
Alpharetta, GA, US - Received
- May 28, 1997
- Decision date
- July 23, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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
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| 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 |
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| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock…DPW · Traditional | 11/20/2025SE |
| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger…DPW · Special | 08/30/2024SE |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerDPW · Traditional | 01/27/2022SE |
| K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek ChargerDPW · Traditional | 10/07/2021SE |
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| K150266 | Remington Medical Inc. Tuohy Epidural NeedlesBSP · Traditional | 06/04/2015SE |
| K130282 | Remington Medical Centrefire 22 Biopsy InstrumentKNW · Traditional | 05/13/2013SE |
| K050884 | Adapter CableDTA · Traditional | 05/19/2005SE |
| K040266 | Core Needle BiopsyKNW · Traditional | 07/09/2004SE |
| K990428 | Drainage BagEXF · Traditional | 08/12/1999SE |
Questions and answers
When was Safe Connect Surgical Cable (S-101-97/S-201-97/FL-601-97) cleared by the FDA?
Safe Connect Surgical Cable (S-101-97/S-201-97/FL-601-97) (K971968) received a 510(k) decision of Substantially Equivalent on July 23, 1997, 56 days after the submission was received.
What is the product code of K971968?
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.