Cordis High-Torque Temp. Pervenous Lead W/Depth Ma
FDA 510(k) K851913 · Cordis Corp.
510(k) numberK851913
Submission
- Device name
- Cordis High-Torque Temp. Pervenous Lead W/Depth Ma
- Applicant
- Cordis Corp.
Miami, FL, US - Received
- May 1, 1985
- Decision date
- September 16, 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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Questions and answers
When was Cordis High-Torque Temp. Pervenous Lead W/Depth Ma cleared by the FDA?
Cordis High-Torque Temp. Pervenous Lead W/Depth Ma (K851913) received a 510(k) decision of Substantially Equivalent on September 16, 1985, 138 days after the submission was received.
What is the product code of K851913?
The FDA product code is LDF – Electrode, Pacemaker, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.3680.