FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003
K Number: K111488
·
Decision Jun 30, 2011
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
14
Review Days
30
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Basic Information
- Device Name
- MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003
- K Number
- K111488
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bridgepoint Medical
- Date Received
- May 31, 2011
- Decision Date
- June 30, 2011
- Product Code
- DQX
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 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 |
| K120533 | BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES | May 22, 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 |
| 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 |