GW 35 Guide Wire
FDA 510(k) K772147 · Sorensen Research
510(k) numberK772147
Submission
- Device name
- GW 35 Guide Wire
- Applicant
- Sorensen Research
Mchenry, IL, US - Received
- November 14, 1977
- Decision date
- November 28, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FIF – Set, Dialysis, Single Needle With Uni-Directional Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FIF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K873279 | 8810 Pump-Pump Single Needle DeviceFIF · Traditional | Cd Medical, Inc. | 10/23/1987SE |
| K820173 | Cobe Single-Needle Controller #18-756FIF · Traditional | Cobe Laboratories, Inc. | 03/23/1982SE |
| K802230 | Bellco Single Needle Double Head PumpFIF · Traditional | Cardio Med Supplies, Inc. | 12/22/1980SE |
| K801967 | Medcomp Femoral Vein CatheterFIF · Traditional | Medical Components, Inc. | 09/26/1980SE |
| K792174 | Model DM 353 & DM-353-L Single NeedleFIF · Traditional | Extracorporeal Medical Specialities, Inc. | 11/16/1979SE |
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| K833096 | Transducer Dome DS106DRS · Traditional | 11/03/1983SE |
| K833095 | Transducer Dome SD105DRS · Traditional | 11/03/1983SE |
| K833094 | Transducer Dome SD104DRS · Traditional | 11/03/1983SE |
| K832957 | Flow-Directed Heparin Coated ThermodilDYG · Traditional | 09/29/1983SE |
| K831506 | Disp. Transducer W/Monitoring Kit TransDRS · Traditional | 08/12/1983SE |
| K831939 | Tall Floor Stand TFS-01GCX · Traditional | 07/19/1983SE |
| K831505 | Thoracic Gauge #TG-60 -Vacuum RegulatorKDP · Traditional | 07/12/1983SE |
| K820706 | Waterless Seal & Vacuum RegulatorKDP · Traditional | 04/09/1982SE |
Questions and answers
When was GW 35 Guide Wire cleared by the FDA?
GW 35 Guide Wire (K772147) received a 510(k) decision of Substantially Equivalent on November 28, 1977, 14 days after the submission was received.
What is the product code of K772147?
The FDA product code is FIF – Set, Dialysis, Single Needle With Uni-Directional Pump, a Class II (moderate risk) device regulated under 21 CFR 876.5820.