FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP
K Number: K132008
·
Decision Jul 30, 2013
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
102
Applicant Total
209
Review Days
29
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Basic Information
- Device Name
- 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP
- K Number
- K132008
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3620
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- July 1, 2013
- Decision Date
- July 30, 2013
- Product Code
- DTD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DTD | Pacemaker Lead Adaptor | FDA class 2 | Cardiovascular |
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