Catheter Connector, Argyle Tubing
FDA 510(k) K760524 · Sherwood Medical Industries
510(k) numberK760524
Submission
- Device name
- Catheter Connector, Argyle Tubing
- Applicant
- Sherwood Medical Industries
Mchenry, IL, US - Received
- August 26, 1976
- Decision date
- November 2, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GCD – Connector, Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GCD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952470 | Acti-Flex Low, Medium, Rescare I, Rescare Ii.GCD · Traditional | R-Group Intl. | 11/28/1995SE |
| K940198 | L-Cath Connector AssemblyGCD · Traditional | Luther Medical Products, Inc. | 12/15/1994SE |
| K863446 | Angiomed High Pressure ConnectorsGCD · Traditional | Angiomed U.S., Inc. | 09/23/1986SE |
| K851196 | Incision DrainGCD · Traditional | Sil-Med Corp. | 06/04/1985SE |
| K851921 | Y ConnectorGCD · Traditional | Sil-Med Corp. | 05/17/1985SE |
| K760382 | ConnectorsGCD · Traditional | B. Braun Instruments | 11/02/1976SE |
| K760203 | Tube, Sterile Non-Conductive ConnectingGCD · Traditional | Ipco Corp. | 07/19/1976SE |
More from Ipco Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K801070 | Sherwood Disposable Endometrial SamplesHHK · Traditional | 07/21/1980SE |
| K801071 | Lancer Glucose Rate Reagent KitCGA · Traditional | 05/23/1980SE |
| K792014 | Lancer L-Ina Buffer, Polymer, Wash SoluJZW · Traditional | 11/13/1979SE |
| K792013 | Lancer L-Ina Human Reference SerumJIX · Traditional | 11/13/1979SE |
| K782077 | Lancer Ice CubeJRM · Traditional | 04/03/1979SE |
| K790523 | Argyle Esophageal StethoscopeBZW · Traditional | 03/27/1979SE |
| K790196 | Monoject Arterial Blood Sampling DeviceCBT · Traditional | 03/13/1979SE |
| K790197 | Reagent Kit, Lancer GlucoseJJF · Traditional | 03/12/1979SE |
| K781459 | Monoject Scale MagnifierHJY · Traditional | 10/24/1978SE |
| K781060 | Monoject Endosseous Dental ImplantDZE · Traditional | 08/14/1978SE |
Questions and answers
When was Catheter Connector, Argyle Tubing cleared by the FDA?
Catheter Connector, Argyle Tubing (K760524) received a 510(k) decision of Substantially Equivalent on November 2, 1976, 68 days after the submission was received.
What is the product code of K760524?
The FDA product code is GCD – Connector, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.