Flowclamp CAT.#1011 & 1012
FDA 510(k) K802009 · Pollak (Intl.), Ltd.
510(k) numberK802009
Submission
- Device name
- Flowclamp CAT.#1011 & 1012
- Applicant
- Pollak (Intl.), Ltd.
Mchenry, IL, US - Received
- August 20, 1980
- Decision date
- October 31, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FKK – Clamp, Line
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4730
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FKK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K854517 | New Travenol Roller Clamp-Solution Admin. SetFKK · Traditional | Travenol Laboratories, S.A. | 12/02/1985SE |
| K854512 | Tubing Clamp CAT#1000-AFKK · Traditional | Rao Medical Devices, Inc. | 12/02/1985SE |
| K844121 | Clamp, Tubing, LineFKK · Traditional | Dyn-A-Med Products | 12/17/1984SE |
| K831689 | Empty Dialysate ContainerFKK · Traditional | Delmed, Inc. | 08/11/1983SE |
| K822551 | Amp Capd Unispike Aministration SetFKK · Traditional | American Medical Products, Inc. | 10/13/1982SE |
More from American Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K000227 | UmbicutHFW · Traditional | 04/27/2000SE |
| K810049 | Pedicat*KMJ · Traditional | 04/21/1981SE |
| K810050 | Vecafix*KGX · Traditional | 03/26/1981SE |
| K802011 | Infussion Alarm System I.A.S. CAT.#1118FLN · Traditional | 10/31/1980SE |
| K802017 | Dressing Change Set CAT.#910-930KDD · Traditional | 10/10/1980SE |
| K802007 | Pediwet=Guaze Impregnated with PetrolFRQ · Traditional | 09/26/1980SE |
| K802022 | Sterile Guaze Swabs CAT.#301-420EFQ · Traditional | 09/16/1980SE |
| K802021 | Pediband CAT.#195-197NAD · Traditional | 09/16/1980SE |
| K802019 | Suture Removal Set CAT.#906KDD · Traditional | 09/16/1980SE |
| K802016 | Eye Applicators CAT.#980-983KXF · Traditional | 09/16/1980SE |
Questions and answers
When was Flowclamp CAT.#1011 & 1012 cleared by the FDA?
Flowclamp CAT.#1011 & 1012 (K802009) received a 510(k) decision of Substantially Equivalent on October 31, 1980, 72 days after the submission was received.
What is the product code of K802009?
The FDA product code is FKK – Clamp, Line, a Class I (low risk) device regulated under 21 CFR 876.4730.