Thoro/Cath Straight Thoracic Right Angle
FDA 510(k) K853131 · J. H. Emerson Co.
510(k) numberK853131
Submission
- Device name
- Thoro/Cath Straight Thoracic Right Angle
- Applicant
- J. H. Emerson Co.
Cambridge, MA, US - Received
- July 26, 1985
- Decision date
- September 5, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBS – Catheter, Ventricular, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GBS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K912645 | Atriums PDR Thoracic CatheterGBS · Traditional | Atrium Medical Corp. | 09/13/1991SE |
| K883887 | Axiom Atraum Wound DrainsGBS · Traditional | Axiom, Inc. | 02/17/1989SE |
| K881873 | Introduction/Drainage Catheter & AccessGBS · Traditional | Sheridan Catheter Corp. | 05/18/1988SE |
| K880895 | Uresil Wound Drain TrocarGBS · Traditional | Uresil Corp. | 03/14/1988SE |
| K880376 | Novo Vivo Suction Catheter Vessel W/Mucose TrapGBS · Traditional | Genesis Industries, Inc. | 02/16/1988SE |
| K873377 | Closed Chest Drainage Set W/SuturesGBS · Traditional | Gish Biomedical, Inc. | 10/28/1987SE |
| K872460 | AN3000 Mahoney DrainGBS · Traditional | H.W. Andersen Products, Inc. | 07/23/1987SE |
| K872459 | AN3100 Mulholland DrainGBS · Traditional | H.W. Andersen Products, Inc. | 07/21/1987SE |
| K872457 | AN3500 Worth DrainGBS · Traditional | H.W. Andersen Products, Inc. | 07/21/1987SE |
| K870015 | Hci All Purpose Drain/Catheter SetGBS · Traditional | Health Care Innovations, Inc. | 02/06/1987SE |
More from Health Care Innovations, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002598 | Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000 W/Manual TimingNHJ · Special | 11/22/2000SE |
| K920910 | Oxygen Powered Resuscitator for CPRBTL · Traditional | 01/12/1993SE |
| K924174 | Emerson In-Exsufflator, Models 2-CM & 2-CANHJ · Traditional | 11/17/1992SE |
| K902764 | Emerson 33-AN Negative Pressure Respirator AlarmBYT · Traditional | 11/19/1990SE |
| K896721 | Model 7-AT Treatment ChamberLGM · Traditional | 01/22/1990SE |
| K881808 | Emerson Chest Respirator, Model 33-CREBYT · Traditional | 08/04/1988SE |
| K873489 | Emerson Dispos Thoracic Drainage Set - 551-8000GCX · Traditional | 12/29/1987SE |
| K872937 | 97-TD Emerson Timer/Dimmer ControlIQA · Traditional | 09/24/1987SE |
| K872936 | 97-D Emerson Dimmer ControlIQA · Traditional | 09/24/1987SE |
| K864379 | Emerson 3MV Volume VentilatorCBK · Traditional | 12/15/1986SE |
Questions and answers
When was Thoro/Cath Straight Thoracic Right Angle cleared by the FDA?
Thoro/Cath Straight Thoracic Right Angle (K853131) received a 510(k) decision of Substantially Equivalent on September 5, 1985, 41 days after the submission was received.
What is the product code of K853131?
The FDA product code is GBS – Catheter, Ventricular, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4200.