FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508
K Number: K042381
·
Decision Dec 28, 2004
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
12
Review Days
118
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Basic Information
- Device Name
- CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508
- K Number
- K042381
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acumen Medical, Inc.
- Date Received
- September 1, 2004
- Decision Date
- December 28, 2004
- Product Code
- DQY
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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Other Clearances by Acumen Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K083855 | MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59 | Feb 17, 2009 | Substantially Equivalent |
| K080500 | MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 | Mar 13, 2008 | Substantially Equivalent |
| K070396 | MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45 | May 22, 2007 | Substantially Equivalent |
| K070051 | ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM | Apr 6, 2007 | Substantially Equivalent |
| K070197 | ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY | Feb 23, 2007 | Substantially Equivalent |
| K062145 | MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90 | Aug 23, 2006 | Substantially Equivalent |
| K062084 | 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 | Aug 18, 2006 | Substantially Equivalent |
| K053400 | ACUMEN SINGLE-LUMEN DELIVERY SHEATH | Jun 19, 2006 | Substantially Equivalent |
| K051515 | MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 | Sep 1, 2005 | Substantially Equivalent |
| K050015 | MODIFIED ACUMEN SHEATH, MODEL TTWO767 | Feb 3, 2005 | Substantially Equivalent |