FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5
K Number: K022075
·
Decision Sep 19, 2002
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
104
Applicant Total
31
Review Days
85
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Basic Information
- Device Name
- DISPOSABLE TEMPORARY PACING CABLE,MODELS CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5
- K Number
- K022075
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cp Medical
- Date Received
- June 26, 2002
- Decision Date
- September 19, 2002
- Product Code
- DSA
- 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 |
|---|---|---|---|
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | FDA class 2 | Cardiovascular |
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|---|---|---|---|
| K094028 | CP-FIBER (ORTHOFIBER) | Mar 18, 2010 | Substantially Equivalent |
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| K071550 | PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS | Jul 18, 2007 | Substantially Equivalent |
| K060987 | OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 | Nov 2, 2006 | Substantially Equivalent |
| K041894 | ORTHOFIBER | Sep 17, 2004 | Substantially Equivalent |
| K034062 | CP SLEEVE AND RIVER SLEEVE | Jan 30, 2004 | Substantially Equivalent |
| K024372 | CP MEDICAL BONE WAX | Jun 19, 2003 | Substantially Equivalent |
| K030786 | MONO-SWIFT | May 6, 2003 | Substantially Equivalent |
| K030351 | STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE | Mar 28, 2003 | Substantially Equivalent |
| K023710 | VISORB SWIFT | Jan 17, 2003 | Substantially Equivalent |