V-Pace(Tm) Transluminal Ventricular/ Model SP5540
FDA 510(k) K864507 · Spectramed, Inc.
510(k) numberK864507
Submission
- Device name
- V-Pace(Tm) Transluminal Ventricular/ Model SP5540
- Applicant
- Spectramed, Inc.
Findley, MN, US - Received
- November 14, 1986
- Decision date
- March 6, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDF – Electrode, Pacemaker, Temporary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3680
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K173923 | Temporary Cardiac Pacing WireLDF · Traditional | ETHICON, Inc. | 08/02/2018SE |
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| K885235 | Safe-Draw(Tm) Blood Sampling Reservoir & Access.DSK · Traditional | 01/25/1989SE |
| K881825 | Models SP5825/SP5835/SP5845/SP5855 Percu. SheathDYB · Traditional | 09/28/1988SE |
| K875337 | Heparin Coated Luminal Pacing CatheterDQO · Traditional | 05/25/1988SE |
| K880740 | Model TA-CS10 Spectraject Control SyringeDQF · Traditional | 03/22/1988SE |
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Questions and answers
When was V-Pace(Tm) Transluminal Ventricular/ Model SP5540 cleared by the FDA?
V-Pace(Tm) Transluminal Ventricular/ Model SP5540 (K864507) received a 510(k) decision of Substantially Equivalent on March 6, 1987, 112 days after the submission was received.
What is the product code of K864507?
The FDA product code is LDF – Electrode, Pacemaker, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.3680.