FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRESSURE MONITORING LINES
K Number: K802326
·
Decision Oct 10, 1980
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
3
Applicant Total
19
Review Days
17
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Basic Information
- Device Name
- PRESSURE MONITORING LINES
- K Number
- K802326
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.2620
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Stanco Medical, Inc.
- Date Received
- September 23, 1980
- Decision Date
- October 10, 1980
- Product Code
- DRI
- 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 |
|---|---|---|---|
| DRI | Monitor, Line Isolation | FDA class 1 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRI), ordered by most recent decision date.
CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR
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FDA Class 1
·Cardiovascular
CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S
FDA 510(k)
FDA Class 1
·Cardiovascular
HEART MONITOR BRACELET ALARM
FDA 510(k)
FDA Class 1
·Cardiovascular
Other Clearances by Stanco Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K810642 | ATRIAL-VENTRICULAR PACING ELECTRODE KIT | Apr 8, 1981 | Substantially Equivalent |
| K810643 | UNIVERSAL PACING ELECTRODE KIT | Apr 8, 1981 | Substantially Equivalent |
| K802289 | PERICARDIOCENTESIS KIT | Nov 26, 1980 | Substantially Equivalent |
| K802288 | SWAN GANZ CATHETER PLACEMENT KIT | Nov 20, 1980 | Substantially Equivalent |
| K802287 | RIGHT ATRIAL LINE KIT | Nov 20, 1980 | Substantially Equivalent |
| K802259 | TRANSVENOUS PACEMAKER ELECTRODE KIT | Oct 23, 1980 | Substantially Equivalent |
| K802290 | REGIONAL INTRAVENOUS ANESTHESIA KIT | Oct 17, 1980 | Substantially Equivalent |
| K802260 | VASCULAR CATHETER WIREGUIDES | Oct 10, 1980 | Substantially Equivalent |
| K802328 | DISP. TOUGY-BORST TYPE ADAPTOR W/PORT | Oct 10, 1980 | Substantially Equivalent |
| K802327 | SHEATH DILATOR SET | Oct 10, 1980 | Substantially Equivalent |