FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH
K Number: K854601
·
Decision Jan 10, 1986
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
74
Applicant Total
42
Review Days
53
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
- SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH
- K Number
- K854601
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5120
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Concord Laboratories, Inc.
- Date Received
- November 18, 1985
- Decision Date
- January 10, 1986
- Product Code
- BSO
- 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 |
|---|---|---|---|
| BSO | Catheter, Conduction, Anesthetic | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BSO), ordered by most recent decision date.
EDEN ControlCath
FDA 510(k)
FDA Class 2
·Anesthesiology
Perifix FX Catheter; Contiplex FX Catheter
FDA 510(k)
FDA Class 2
·Anesthesiology
Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)
FDA 510(k)
FDA Class 2
·Anesthesiology
SubQKath Catheter and Needle Set
FDA 510(k)
FDA Class 2
·Anesthesiology
Percutaneous Introducer
FDA 510(k)
FDA Class 2
·Anesthesiology
C-CAT Anaesthesia Catheter kit
FDA 510(k)
FDA Class 2
·Anesthesiology
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 |
| 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 |