Badgwell Sampling Catheter
FDA 510(k) K870858 · Dryden Corp.
510(k) numberK870858
Submission
- Device name
- Badgwell Sampling Catheter
- Applicant
- Dryden Corp.
Indianapolis, IN, US - Received
- March 3, 1987
- Decision date
- May 14, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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|---|---|---|
| K880923 | Patient Ventilator IsolatorCBK · Traditional | 09/06/1988SE |
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| K873928 | Universal TourniquetGAX · Traditional | 10/23/1987SE |
| K873927 | Reuseable Breathing TubesBZO · Traditional | 10/20/1987SE |
| K870859 | Bag-Tail Bleed ValveCAI · Traditional | 08/03/1987SE |
| K871386 | Breathing CircuitCAI · Traditional | 05/29/1987SE |
| K861540 | Disposable Berman and Guedel AirwaysCAE · Traditional | 05/02/1986SE |
| K850644 | Nasopharyngeal Airway-RobertazziBTQ · Traditional | 03/21/1985SE |
| K842843 | Dryden Scavenger Interface System · Traditional | 07/27/1984SE |
Questions and answers
When was Badgwell Sampling Catheter cleared by the FDA?
Badgwell Sampling Catheter (K870858) received a 510(k) decision of Substantially Equivalent on May 14, 1987, 72 days after the submission was received.
What is the product code of K870858?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.