Catheter, Cebtral Venous, 2N1501
FDA 510(k) K771861 · Travenol Laboratories, S.A.
510(k) numberK771861
Submission
- Device name
- Catheter, Cebtral Venous, 2N1501
- Applicant
- Travenol Laboratories, S.A.
Mchenry, IL, US - Received
- October 3, 1977
- Decision date
- November 28, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JCY – Catheter, Infusion
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code JCY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K863982 | Vas-Cath Pericardiocentesis Catheter, Set & TrayJCY · Traditional | Vas-Cath of Canada , Ltd. | 10/24/1986SE |
| K840324 | Silicone Sump Drain 20 & 40 FrenchJCY · Traditional | Superior Plastic Products Corp. | 04/25/1984SE |
| K834615 | Triple Lumen Infusioncatheters-JCY · Traditional | Medical Components, Inc. | 02/14/1984SE |
| K831453 | Silcath Central Catheter Tray W/18 GaJCY · Traditional | Argon Medical Corp. | 07/28/1983SE |
| K831451 | Silcath Central Catheter Tray Size-JCY · Traditional | Argon Medical Corp. | 06/08/1983SE |
| K822096 | Chemotherapy Infusion CatheterJCY · Traditional | American Heyer Schulte | 04/12/1983SE |
| K813606 | Silicone Elastomer Infusion CatheterJCY · Traditional | Quest Medical, Inc. | 01/18/1982SE |
| K791372 | Jelco & Kvo Catheter Placement UnitJCY · Traditional | Jelco Laboratories | 09/12/1979SE |
| K760760 | Catheter, Intravascular (Argyle IV SK)JCY · Traditional | Sherwood Medical Industries | 12/09/1976SE |
| K760391 | Catheter, Vein (Braunula)JCY · Traditional | B. Braun Instruments | 11/02/1976SE |
More from B. Braun Instruments
| 510(k) | Device | Decision |
|---|---|---|
| K874181 | Baxter Bedside SystemFRN · Traditional | 02/22/1988SE |
| K873894 | Continu-Flo Solution W/Check Valve 2 Y-Inject SiteFPA · Traditional | 11/05/1987SE |
| K873873 | Resubmitted Micron Transfusion FilterCAK · Traditional | 10/22/1987SE |
| K873984 | Automatic Peritoneal Dialysis Cycler Set (5C4437)KDJ · Traditional | 10/20/1987SE |
| K872364 | Hemodialysis (SPS), Model 550, Code 5M1309FII · Traditional | 10/13/1987SE |
| K872652 | Upgraded Auto Peritoneal Dialysis Cycler SystemFKX · Traditional | 09/30/1987SE |
| K870801 | Flo-Gard 6200 Volumetric Infusion/Pumping BloodFRN · Traditional | 09/04/1987SE |
| K871908 | IV Administration SetBRZ · Traditional | 07/27/1987SE |
| K871471 | Capillary Flow Dialyzers Models ST-12 & ST-15FJI · Traditional | 06/12/1987SE |
| K865029 | Continu-Flo Solution Admin. Set W/In-Line FilterFPB · Traditional | 04/17/1987SE |
Questions and answers
When was Catheter, Cebtral Venous, 2N1501 cleared by the FDA?
Catheter, Cebtral Venous, 2N1501 (K771861) received a 510(k) decision of Substantially Equivalent on November 28, 1977, 56 days after the submission was received.
What is the product code of K771861?
The FDA product code is JCY – Catheter, Infusion, a Class I (low risk) device regulated under 21 CFR 878.4200.