FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL DA-53 PRESSURE GUAGE ISOLATOR
K Number: K761325
·
Decision Jan 6, 1977
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
147
Applicant Total
69
Review Days
10
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
- MODEL DA-53 PRESSURE GUAGE ISOLATOR
- K Number
- K761325
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2850
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Extracorporeal Medical Specialities, Inc.
- Date Received
- December 27, 1976
- Decision Date
- January 6, 1977
- Product Code
- DRS
- 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 |
|---|---|---|---|
| DRS | Transducer, Blood-Pressure, Extravascular | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRS), ordered by most recent decision date.
FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
FDA 510(k)
FDA Class 2
·Cardiovascular
Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
FDA 510(k)
FDA Class 2
·Cardiovascular
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
Compass Cast and MAP
FDA 510(k)
FDA Class 2
·Cardiovascular
Disposable Pressure Transducer
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Extracorporeal Medical Specialities, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K843955 | EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR | Nov 29, 1984 | Substantially Equivalent |
| K840532 | HEMOPERFUSION SYSTEM TP-400 | May 30, 1984 | Substantially Equivalent |
| K840262 | HANCOCK PERICARDIAL PATCH | May 30, 1984 | Substantially Equivalent |
| K840146 | EXP* 700 PARALLEL PLATE DIALYZER | Feb 4, 1984 | Substantially Equivalent |
| K840057 | EXP* 500 PARALLEL PLATE DIALYZER | Feb 4, 1984 | Substantially Equivalent |
| K831423 | THERAPEUTIC EXCHANGE SYSTEM | Jan 3, 1984 | Substantially Equivalent |
| K832547 | ULTRAFILTRATION CONTROLLER | Jan 3, 1984 | Substantially Equivalent |
| K833477 | INTERSEPT 40 MICRON FILTER | Dec 27, 1983 | Substantially Equivalent |
| K833476 | INTERSEPT 40 MICRON FILTER W/TUBING | Dec 27, 1983 | Substantially Equivalent |
| K831424 | THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 | Oct 14, 1983 | Substantially Equivalent |