FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES
K Number: K120533
·
Decision May 22, 2012
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
56
Applicant Total
14
Review Days
90
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Basic Information
- Device Name
- BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES
- K Number
- K120533
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bridgepoint Medical
- Date Received
- February 22, 2012
- Decision Date
- May 22, 2012
- Product Code
- PDU
- 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 |
|---|---|---|---|
| PDU | Catheter For Crossing Total Occlusions | FDA class 2 | Cardiovascular |
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Other Clearances by Bridgepoint Medical
| K Number | Device Name | ||
|---|---|---|---|
| K122795 | STINGRAY GUIDEWIRES | Nov 8, 2012 | Substantially Equivalent |
| K121745 | MANTARAY GUIDEWIRES | Jul 13, 2012 | Substantially Equivalent |
| K120881 | MANTARAY GUIDEWIRES | Apr 18, 2012 | Substantially Equivalent |
| K120129 | MANTARAY CATHETER | Feb 3, 2012 | Substantially Equivalent |
| K113589 | BIGBOSS CATHETER | Jan 4, 2012 | Substantially Equivalent |
| K111963 | BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER | Aug 10, 2011 | Substantially Equivalent |
| K111488 | MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003 | Jun 30, 2011 | Substantially Equivalent |
| K101591 | STINGRAY ORIENTING BALLOON CATHETER | Aug 6, 2010 | Substantially Equivalent |
| K091841 | BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 | Sep 2, 2009 | Substantially Equivalent |
| K081130 | BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER | May 14, 2009 | Substantially Equivalent |