FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER
K Number: K111043
·
Decision Aug 4, 2011
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
72
Applicant Total
430
Review Days
111
Basic Information
- Device Name
- ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER
- K Number
- K111043
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BOSTON SCIENTIFIC CORP.
- Date Received
- April 15, 2011
- Decision Date
- August 4, 2011
- Product Code
- OBJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| OBJ | Catheter, Ultrasound, Intravascular | FDA class 2 | Cardiovascular |
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