3.2-5MM Unipolar Lead Upsizing Kit, Model Ak 100
FDA 510(k) K900605 · Possis Medical, Inc.
510(k) numberK900605
Submission
- Device name
- 3.2-5MM Unipolar Lead Upsizing Kit, Model Ak 100
- Applicant
- Possis Medical, Inc.
Minneapolis, MN, US - Received
- February 8, 1990
- Decision date
- March 6, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTD – Pacemaker Lead Adaptor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3620
- Specialty
- Cardiovascular
- Implant
- Yes
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Questions and answers
When was 3.2-5MM Unipolar Lead Upsizing Kit, Model Ak 100 cleared by the FDA?
3.2-5MM Unipolar Lead Upsizing Kit, Model Ak 100 (K900605) received a 510(k) decision of Substantially Equivalent on March 6, 1990, 26 days after the submission was received.
What is the product code of K900605?
The FDA product code is DTD – Pacemaker Lead Adaptor, a Class II (moderate risk) device regulated under 21 CFR 870.3620.