FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Bullfrog Micro-Infusion Device
K Number: K210339
·
Decision Aug 2, 2021
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
170
Applicant Total
1
Review Days
178
Basic Information
- Device Name
- Bullfrog Micro-Infusion Device
- K Number
- K210339
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mercator MedSystems, Inc.
- Date Received
- February 5, 2021
- Decision Date
- August 2, 2021
- 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.
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
ScleroSafe 150 mm, ScleroSafe 350 mm
FDA 510(k)
FDA Class 2
·Cardiovascular
TriSalus TriNav® LV Infusion System
FDA 510(k)
FDA Class 2
·Cardiovascular
Wallaby 017 Micro Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus Handpiece with 65cm Maceration Wire, Cleaner Plus Handpiece with 135cm Maceration Wire, Cleaner Plus Aspiration Canister
FDA 510(k)
FDA Class 2
·Cardiovascular