Cordis Temporaty Curved Atrial Lead
FDA 510(k) K810041 · Cordis Corp.
510(k) numberK810041
Submission
- Device name
- Cordis Temporaty Curved Atrial Lead
- Applicant
- Cordis Corp.
- Received
- January 7, 1981
- Decision date
- February 5, 1981
- 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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Questions and answers
When was Cordis Temporaty Curved Atrial Lead cleared by the FDA?
Cordis Temporaty Curved Atrial Lead (K810041) received a 510(k) decision of Substantially Equivalent on February 5, 1981, 29 days after the submission was received.
What is the product code of K810041?
The FDA product code is LDF – Electrode, Pacemaker, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.3680.