Numed Temp. Stylet Pacing Parobe 1318694
FDA 510(k) K851845 · NuMED, Inc.
510(k) numberK851845
Submission
- Device name
- Numed Temp. Stylet Pacing Parobe 1318694
- Applicant
- NuMED, Inc.
Hopkinton, NY, US - Received
- April 26, 1985
- Decision date
- August 29, 1985
- 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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| K171253 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar…LDF · Special | Medtronic | 05/25/2017SE |
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Questions and answers
When was Numed Temp. Stylet Pacing Parobe 1318694 cleared by the FDA?
Numed Temp. Stylet Pacing Parobe 1318694 (K851845) received a 510(k) decision of Substantially Equivalent on August 29, 1985, 125 days after the submission was received.
What is the product code of K851845?
The FDA product code is LDF – Electrode, Pacemaker, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.3680.