FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.
K Number: K885235
·
Decision Jan 25, 1989
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
76
Applicant Total
13
Review Days
36
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
- SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.
- K Number
- K885235
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1110
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Spectramed, Inc.
- Date Received
- December 20, 1988
- Decision Date
- January 25, 1989
- Product Code
- DSK
- 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 |
|---|---|---|---|
| DSK | Computer, Blood-Pressure | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DSK), ordered by most recent decision date.
Endophys Blood Pressure Monitor model BPM-30
FDA 510(k)
FDA Class 2
·Cardiovascular
Endophys Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDOPHYS BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Spectramed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K896122 | AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED | Jan 19, 1990 | Substantially Equivalent |
| K892941 | CCO SYSTEM MODEL SP1467,SP5567,SP6267 | Nov 6, 1989 | Substantially Equivalent |
| K895323 | MODEL DT-BAL, BALANCE SAVER | Oct 24, 1989 | Substantially Equivalent |
| K894362 | MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP | Aug 15, 1989 | Substantially Equivalent |
| K881857 | AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. | Feb 1, 1989 | Substantially Equivalent |
| K881825 | MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH | Sep 28, 1988 | Substantially Equivalent |
| K875337 | HEPARIN COATED LUMINAL PACING CATHETER | May 25, 1988 | Substantially Equivalent |
| K880740 | MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE | Mar 22, 1988 | Substantially Equivalent |
| K873168 | SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS | Jan 12, 1988 | Substantially Equivalent |
| K871573 | CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS | Sep 16, 1987 | Substantially Equivalent |