FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger
K Number: K211589
·
Decision Jan 27, 2022
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
19
Review Days
248
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Basic Information
- Device Name
- VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger
- K Number
- K211589
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Remington Medical, Inc.
- Date Received
- May 24, 2021
- Decision Date
- January 27, 2022
- Product Code
- DPW
- 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 |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DPW), ordered by most recent decision date.
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VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)
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Other Clearances by Remington Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) | Nov 20, 2025 | Substantially Equivalent |
| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01) | Aug 30, 2024 | Substantially Equivalent |
| K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger | Oct 7, 2021 | Substantially Equivalent |
| K191315 | Remington Medical, Inc. Automatic Cutting Needle (NAC) | Jul 12, 2019 | Substantially Equivalent |
| K150266 | Remington Medical Inc. Tuohy Epidural Needles | Jun 4, 2015 | Substantially Equivalent |
| K130282 | REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT | May 13, 2013 | Substantially Equivalent |
| K050884 | ADAPTER CABLE | May 19, 2005 | Substantially Equivalent |
| K040266 | CORE NEEDLE BIOPSY | Jul 9, 2004 | Substantially Equivalent |
| K990428 | DRAINAGE BAG | Aug 12, 1999 | Substantially Equivalent |
| K983621 | NEEDLE GUIDE | Nov 3, 1998 | Substantially Equivalent |