FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC
K Number: K820882
·
Decision Oct 18, 1982
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
161
Applicant Total
132
Review Days
202
Basic Information
- Device Name
- PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC
- K Number
- K820882
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3535
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- DATASCOPE CORP.
- Date Received
- March 30, 1982
- Decision Date
- October 18, 1982
- Product Code
- DSP
- 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 |
|---|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | FDA class 2 | Cardiovascular |
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Other Clearances by DATASCOPE CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump | Jul 2, 2015 | Substantially Equivalent |
| K133074 | MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES | Dec 12, 2013 | Substantially Equivalent |
| K071805 | NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX | Sep 25, 2007 | Substantially Equivalent |
| K062569 | SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING | Feb 14, 2007 | Substantially Equivalent |
| K062098 | SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX | Feb 5, 2007 | Substantially Equivalent |
| K063525 | DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM | Jan 5, 2007 | Substantially Equivalent |
| K062754 | GAS MODULE SE, MODEL 0998-00-0481-02 | Nov 2, 2006 | Substantially Equivalent |
| K051897 | TRIO MONITOR | Aug 12, 2005 | Substantially Equivalent |
| K042016 | DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER | Sep 23, 2004 | Substantially Equivalent |
| K041907 | TRIO MONITOR | Jul 23, 2004 | Substantially Equivalent |