Cpi Lead Adapters, Models 6017, 6018 and 6020
FDA 510(k) K041574 · Guidant Corporation
510(k) numberK041574
Submission
- Device name
- Cpi Lead Adapters, Models 6017, 6018 and 6020
- Applicant
- Guidant Corporation
St Paul, MN, US - Received
- June 14, 2004
- Decision date
- July 12, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
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 Cpi Lead Adapters, Models 6017, 6018 and 6020 cleared by the FDA?
Cpi Lead Adapters, Models 6017, 6018 and 6020 (K041574) received a 510(k) decision of Substantially Equivalent on July 12, 2004, 28 days after the submission was received.
What is the product code of K041574?
The FDA product code is DTD – Pacemaker Lead Adaptor, a Class II (moderate risk) device regulated under 21 CFR 870.3620.