FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110
K Number: K864535
·
Decision Jan 6, 1987
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
42
Review Days
50
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Basic Information
- Device Name
- TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110
- K Number
- K864535
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Concord Laboratories, Inc.
- Date Received
- November 17, 1986
- Decision Date
- January 6, 1987
- Product Code
- BSY
- 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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | FDA class 1 | Anesthesiology |
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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 |
| 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 |
| K840987 | VAPORIZED HEPARIN | Apr 5, 1984 | Substantially Equivalent |