FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXCELSIOR 1018 MICROCATHETER
K Number: K994155
·
Decision Aug 3, 2000
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
174
Applicant Total
19
Review Days
238
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
- EXCELSIOR 1018 MICROCATHETER
- K Number
- K994155
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific, Target
- Date Received
- December 9, 1999
- Decision Date
- August 3, 2000
- Product Code
- KRA
- 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 |
|---|---|---|---|
| KRA | Catheter, Continuous Flush | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KRA), ordered by most recent decision date.
Verge Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
TruSelect 2.6 Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
InVera Infusion Device
FDA 510(k)
FDA Class 2
·Cardiovascular
Micro Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)
FDA 510(k)
FDA Class 2
·Cardiovascular
Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Boston Scientific, Target
| K Number | Device Name | ||
|---|---|---|---|
| K031049 | GUGLIELMI DETACHABLE COIL (GDC) | Aug 1, 2003 | Substantially Equivalent |
| K031168 | MATRIX STRETCH RESISTANT DETACHABLE COIL | May 14, 2003 | Substantially Equivalent |
| K030475 | GDC STRETCH RESISTANT DETACHABLE COIL | Mar 14, 2003 | Substantially Equivalent |
| K022860 | ATLANTIS PV IMAGING CATHETER, MODEL 36456 | Nov 21, 2002 | Substantially Equivalent |
| K022357 | TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 | Oct 16, 2002 | Substantially Equivalent |
| K021494 | GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4 | Jun 6, 2002 | Substantially Equivalent |
| K014109 | IN-TIME RETRIEVAL DEVICE | Mar 12, 2002 | Substantially Equivalent |
| K012985 | MATRIX DETACHABLE COILS | Jan 31, 2002 | Substantially Equivalent |
| K013789 | EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 | Dec 6, 2001 | Substantially Equivalent |
| K010853 | GUIDER SOFTIP GUIDING CATHETER XF 5F | Apr 18, 2001 | Substantially Equivalent |