Angiomed High Pressure Connectors
FDA 510(k) K863446 · Angiomed U.S., Inc.
510(k) numberK863446
Submission
- Device name
- Angiomed High Pressure Connectors
- Applicant
- Angiomed U.S., Inc.
Anaheim, CA, US - Received
- September 8, 1986
- Decision date
- September 23, 1986
- 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 |
| K851196 | Incision DrainGCD · Traditional | Sil-Med Corp. | 06/04/1985SE |
| K851921 | Y ConnectorGCD · Traditional | Sil-Med Corp. | 05/17/1985SE |
| K760524 | Catheter Connector, Argyle TubingGCD · Traditional | Sherwood Medical Industries | 11/02/1976SE |
| 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 |
|---|---|---|
| K874771 | Angiomed Introducing SetsDWB · Traditional | 01/12/1988SE |
| K874585 | Angiomed Osty-Cut Bone Biopsy NeedleDWO · Traditional | 12/02/1987SE |
| K864225 | Angiomed Ureteral D&M Sets/Ureteroscopy Guid StentFAD · Traditional | 01/30/1987SE |
| K863386 | Vesico Suprapubic Bladder Drainage & Exchange SetsKOB · Traditional | 10/24/1986SE |
| K862805 | Angiomed Vac-U-Cut Biopsy NeedleGDM · Traditional | 09/29/1986SE |
| K854910 | AngioflowDQO · Traditional | 07/17/1986SE |
| K854912 | Angiomed Guied WiresDQX · Traditional | 04/16/1986SE |
| K854908 | UroflexFAD · Traditional | 03/14/1986SE |
| K855143 | Angiomed Exchange Drainage Catheter SetsKOD · Traditional | 03/11/1986SE |
| K855142 | Angiomed Percutaneous Transhepatic CholangiogtaphyFGE · Traditional | 03/11/1986SE |
Questions and answers
When was Angiomed High Pressure Connectors cleared by the FDA?
Angiomed High Pressure Connectors (K863446) received a 510(k) decision of Substantially Equivalent on September 23, 1986, 15 days after the submission was received.
What is the product code of K863446?
The FDA product code is GCD – Connector, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.