FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EPC FILTER
K Number: K813123
·
Decision Nov 27, 1981
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
23
Applicant Total
152
Review Days
23
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
- EPC FILTER
- K Number
- K813123
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2050
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Codman & Shurtleff, Inc.
- Date Received
- November 4, 1981
- Decision Date
- November 27, 1981
- Product Code
- DRR
- 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 |
|---|---|---|---|
| DRR | Amplifier And Signal Conditioner, Biopotential | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRR), ordered by most recent decision date.
BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117
FDA 510(k)
FDA Class 2
·Cardiovascular
EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391
FDA 510(k)
FDA Class 2
·Cardiovascular
EP AMP, MODEL #901
FDA 510(k)
FDA Class 2
·Cardiovascular
HORIZON 9000/HIS OPTION AMPLIFIER
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDIOLAB AMPLIFIER MODULE (CAM)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Codman & Shurtleff, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set | Jul 20, 2020 | Substantially Equivalent |
| K191237 | CERENOVUS Large Bore Catheter | Nov 8, 2019 | Substantially Equivalent |
| K173192 | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit | Nov 8, 2017 | Substantially Equivalent |
| K172537 | Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag | Oct 16, 2017 | Substantially Equivalent |
| K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) | Oct 3, 2017 | Substantially Equivalent |
| K171862 | GALAXY G3 Mini Microcoil Delivery System | Sep 25, 2017 | Substantially Equivalent |
| K171747 | MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System | Jul 14, 2017 | Substantially Equivalent |
| K171653 | YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up | Jul 3, 2017 | Substantially Equivalent |
| K162563 | YOGA Microcatheter | Jan 5, 2017 | Substantially Equivalent |
| K162437 | Codman EDS3 CSF External Drainage System | Oct 28, 2016 | Substantially Equivalent |