Subclavian Catheter Insertion Tray
FDA 510(k) K802580 · American Pharmaseal Div. Ahsc
510(k) numberK802580
Submission
- Device name
- Subclavian Catheter Insertion Tray
- Applicant
- American Pharmaseal Div. Ahsc
Mchenry, IL, US - Received
- October 15, 1980
- Decision date
- November 12, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KXF – Applicator, Absorbent Tipped, Non-Sterile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6025
- Specialty
- General Hospital
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|---|---|---|---|
| K123184 | Finn Chambers AquaKXF · Traditional | Smartpractice | 12/19/2012SE |
| K103409 | Allergeaze R ClearKXF · Traditional | Smartpractice | 03/15/2011SE |
| K063160 | Allergeaze Patch Test ChambersKXF · Traditional | Smartpractice | 12/22/2006SE |
| K013820 | Finn Chamber (R)KXF · Traditional | Epitest Ltd. OY | 01/30/2002SE |
| K992553 | Iq ChambersKXF · Traditional | Dormer Laboratories, Inc. | 04/12/2000SE |
| K870762 | Ear Applicator, Catalog No. 2229KXF · Traditional | Treace Medical, Inc. | 03/06/1987SE |
| K843720 | Cotton Tipped Applicators, SingleKXF · Traditional | Abco Dealers, Inc. | 10/04/1984SE |
| K820962 | Cotton SwabsKXF · Traditional | Dafoe & Dafoe, Inc. | 04/20/1982SE |
| K813506 | Farrors TMJ Cassette HolderKXF · Traditional | Brell Mar Products, Inc. | 01/29/1982SE |
| K811365 | Hill Top ChamberKXF · Traditional | Hill Top Research, Inc. | 08/20/1981SE |
More from Hill Top Research, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K874022 | Pharmaseal Wound Irrigation DeviceFQH · Traditional | 12/30/1987SE |
| K874517 | Pharmaseal Rubber Urethral CatheterKOD · Traditional | 12/03/1987SE |
| K874045 | Pharmaseal Endoscopy Prep Kit Upper and LowerNWU · Traditional | 12/03/1987SE |
| K873359 | Airlife Volume Venti. Circuit W/Clear Cap Ex ValveCAI · Traditional | 11/06/1987SE |
| K872228 | Pharmaseal Alternating Pressure Pad SystemFNM · Traditional | 09/04/1987SE |
| K872917 | Jinotti Suction/Oxygen Insufflation CatheterBSY · Traditional | 08/11/1987SE |
| K871429 | Antimicrobial Foley CatheterKOD · Traditional | 08/10/1987SE |
| K871770 | American Pharmaseal Wound DressingFRO · Traditional | 06/26/1987SN |
| K870387 | Euromedical, Endosoft Endotracheal TubeBTR · Traditional | 05/08/1987SE |
| K870977 | Pharmaseal T Type Thermocouple 100% Cath./ProbeKOD · Traditional | 04/01/1987SE |
Questions and answers
When was Subclavian Catheter Insertion Tray cleared by the FDA?
Subclavian Catheter Insertion Tray (K802580) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 28 days after the submission was received.
What is the product code of K802580?
The FDA product code is KXF – Applicator, Absorbent Tipped, Non-Sterile, a Class I (low risk) device regulated under 21 CFR 880.6025.