FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STEALTH CATHETER SYSTEM
K Number: K911089
·
Decision May 29, 1991
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
70
Review Days
85
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STEALTH CATHETER SYSTEM
- K Number
- K911089
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Target Therapeutics
- Date Received
- March 5, 1991
- Decision Date
- May 29, 1991
- Product Code
- LIT
- 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LIT), ordered by most recent decision date.
WAVE PTA Balloon Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Armada 14 NC PTA Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amethyst HP PTA OTW 0.035 Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amethyst HP PTA OTW 0.035 Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Target Therapeutics
| K Number | Device Name | ||
|---|---|---|---|
| K965071 | DETACHABLE SLICONE BALLOON (DSB) | Apr 21, 1998 | Substantially Equivalent |
| K964488 | DETACHABLE SILICONE BALLOON (DSB) | Apr 21, 1998 | Substantially Equivalent |
| K964210 | RETRIEVER II | Oct 31, 1997 | Substantially Equivalent |
| K971395 | GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE | Jul 14, 1997 | Substantially Equivalent |
| K965189 | SPINNAKER | Mar 24, 1997 | Substantially Equivalent |
| K964112 | BERENSTEIN COIL | Feb 26, 1997 | Substantially Equivalent |
| K963307 | GDC PATIENT RETURN ELECTTRODE MODEL 45021 | Dec 17, 1996 | Substantially Equivalent |
| K962503 | GUGLIELMI DETACHABLE COIL | Sep 20, 1996 | Substantially Equivalent |
| K961923 | BERENSTEIN COIL | Aug 15, 1996 | Substantially Equivalent |
| K960705 | GUGLIELMI DETACHABLE COIL | May 21, 1996 | Substantially Equivalent |