FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARBA LINGUARDUC
K Number: K771825
·
Decision Oct 6, 1977
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
37
Applicant Total
645
Review Days
9
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
- CARBA LINGUARDUC
- K Number
- K771825
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3710
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- C.R. Bard, Inc.
- Date Received
- September 27, 1977
- Decision Date
- October 6, 1977
- Product Code
- ILQ
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| ILQ | System, Communication, Powered | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ILQ), ordered by most recent decision date.
Noddle(TM)
FDA 510(k)
FDA Class 2
·Physical Medicine
P.A.T. SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
COMFORT KEYBOARD SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
LIGHTWRITER
FDA 510(k)
FDA Class 2
·Physical Medicine
R & D BATTERIES, INC. PART NUMBER 5113
FDA 510(k)
FDA Class 2
·Physical Medicine
MLT-2
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by C.R. Bard, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit | May 29, 2026 | Unknown |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | Mar 17, 2026 | Substantially Equivalent |
| K251864 | Rubber Utility Catheter | Feb 23, 2026 | Substantially Equivalent |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) | May 15, 2025 | Substantially Equivalent |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter, | Jan 31, 2025 | Substantially Equivalent |
| K230356 | Aspirex Thrombectomy System | Mar 31, 2023 | Substantially Equivalent |
| K223177 | Highlander 014 PTA Balloon Dilatation Catheter | Jan 20, 2023 | Substantially Equivalent |
| K222793 | WavelinQ Generator | Oct 17, 2022 | Substantially Equivalent |
| K220270 | Aspirex Thrombectomy System | Jun 21, 2022 | Substantially Equivalent |
| K213203 | Provena(TM) Midline Catheter | May 13, 2022 | Substantially Equivalent |