Coaxial Catheter Set
FDA 510(k) K902694 · Cook Ob/Gyn
510(k) numberK902694
Submission
- Device name
- Coaxial Catheter Set
- Applicant
- Cook Ob/Gyn
Spencer, IN, US - Received
- June 19, 1990
- Decision date
- August 28, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HDR – Cap, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5250
- Specialty
- Obstetrics/Gynecology
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| K222969 | FERTI-LILY Conception CupHDR · Traditional | Rosesta Medical BV | 06/23/2023SE |
| K993953 | Oves Cervical CapHDR · Traditional | Veos , Ltd. | 03/21/2000SESU |
| K945131 | Imagyn Intrauterine Insemination DeviceHDR · Traditional | Imagyn Medical, Inc. | 05/15/1995SE |
| K950714 | Cook Insemination CupHDR · Traditional | Cook Urological, Inc. | 05/11/1995SE |
| K902171 | Minispace(Tm) Iui CatheterHDR · Traditional | Pharmacia, Inc. | 10/05/1990SE |
| K896960 | Intrauterine Insemination CathetersHDR · Traditional | C.R. Bard, Inc. | 06/26/1990SE |
| K900316 | Modified Ham's F-10 Medium and Medium-HepesHDR · Traditional | Irvine Scientific | 04/16/1990SE |
| K900308 | Sperm Select SystemHDR · Traditional | Pharmacia, Inc. | 04/13/1990SE |
| K900162 | DGH A-San Probe HolderHDR · Traditional | Jedmed Instrument Co. | 02/16/1990SE |
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| K023850 | Sydney Ivf Embryo Biopsy MediumMQL · Traditional | 01/22/2003SE |
| K013597 | Tamponade Uterine Balloon Catheter SetKNA · Traditional | 04/17/2002SE |
| K002385 | Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization…MQL · Traditional | 09/18/2000SE |
| K002383 | Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm Gradient KitMQL · Traditional | 09/13/2000SE |
| K983595 | Transmyometrial Embryo Transfer SetMQF · Traditional | 02/08/1999SE |
| K983596 | Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes, Holding Pipettes…MQH · Traditional | 02/05/1999SE |
| K983642 | Cook Mini-IncubatorMQG · Traditional | 02/01/1999SE |
| K983593 | Ovum Pick-Up Aspiration NeedlesMQE · Traditional | 01/21/1999SE |
Questions and answers
When was Coaxial Catheter Set cleared by the FDA?
Coaxial Catheter Set (K902694) received a 510(k) decision of Substantially Equivalent on August 28, 1990, 70 days after the submission was received.
What is the product code of K902694?
The FDA product code is HDR – Cap, Cervical, a Class II (moderate risk) device regulated under 21 CFR 884.5250.