Medtronic Model 5455 Disposable Surgical Cable
FDA 510(k) K863547 · Medtronic Vascular
510(k) numberK863547
Submission
- Device name
- Medtronic Model 5455 Disposable Surgical Cable
- Applicant
- Medtronic Vascular
Lawrence, MA, US - Received
- September 12, 1986
- Decision date
- October 31, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5550
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K961138 | Esort II + 400 Series MonitorDRO · Traditional | Medical Data Electronics | 12/10/1996SE |
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Questions and answers
When was Medtronic Model 5455 Disposable Surgical Cable cleared by the FDA?
Medtronic Model 5455 Disposable Surgical Cable (K863547) received a 510(k) decision of Substantially Equivalent on October 31, 1986, 49 days after the submission was received.
What is the product code of K863547?
The FDA product code is DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), a Class II (moderate risk) device regulated under 21 CFR 870.5550.