FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE
K Number: K880740
·
Decision Mar 22, 1988
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
2
Applicant Total
13
Review Days
27
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Basic Information
- Device Name
- MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE
- K Number
- K880740
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1670
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Spectramed, Inc.
- Date Received
- February 24, 1988
- Decision Date
- March 22, 1988
- Product Code
- DQF
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| DQF | Actuator, Syringe, Injector Type | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQF), ordered by most recent decision date.
VERSA-VIAL
FDA 510(k)
FDA Class 2
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ALCON FLUID INJECTOR
FDA 510(k)
FDA Class 2
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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 |
| K885235 | SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. | Jan 25, 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 |
| 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 |