FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHEATH DILATOR SET
K Number: K802327
·
Decision Oct 10, 1980
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
103
Applicant Total
19
Review Days
17
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Basic Information
- Device Name
- SHEATH DILATOR SET
- K Number
- K802327
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Stanco Medical, Inc.
- Date Received
- September 23, 1980
- Decision Date
- October 10, 1980
- Product Code
- DRE
- 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 |
|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | FDA class 2 | Cardiovascular |
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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 |
| K802326 | PRESSURE MONITORING LINES | Oct 10, 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 |