FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VAPORIZED HEPARIN
K Number: K840987
·
Decision Apr 5, 1984
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
57
Applicant Total
42
Review Days
29
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Basic Information
- Device Name
- VAPORIZED HEPARIN
- K Number
- K840987
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1100
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Concord Laboratories, Inc.
- Date Received
- March 7, 1984
- Decision Date
- April 5, 1984
- Product Code
- CBT
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CBT | Arterial Blood Sampling Kit | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CBT), ordered by most recent decision date.
HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM
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SECURE ARTERIAL BLOOD SAMPLING SYSTEM
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ABC IN-LINE BLOOD SAMPLING KIT
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NEEDLE SAFETY COVER
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Other Clearances by Concord Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883840 | DRI-VENT ARTERIAL BLOOD SAMPLING KIT | May 16, 1989 | Unknown |
| K871825 | MECONIUM SUCTION CATHETER | Jun 29, 1987 | Substantially Equivalent |
| K864535 | TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110 | Jan 6, 1987 | Substantially Equivalent |
| K862039 | CONCORD CARE TRAY | Jul 3, 1986 | Unknown |
| K854601 | SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH | Jan 10, 1986 | Substantially Equivalent |
| K854327 | SUBCUTANEOUS TUNNELING NEEDLES & HANDLES | Nov 13, 1985 | Substantially Equivalent |
| K851134 | REGIONAL ANESTHESIA TRAYS | Jul 15, 1985 | Unknown |
| K842095 | EPIDURAL TRAYS | Jul 3, 1984 | Substantially Equivalent |
| K841486 | ARTERIAL BLOOD SAMPLING KITS | May 23, 1984 | Substantially Equivalent |
| K840986 | PREFILLED PULSATOR SYRINGE | Apr 5, 1984 | Substantially Equivalent |