510(k) K970159
- Device
- FLEX-NECK PD CATHETER
- Applicant
- JANIN GROUP, INC.
- 510(k) number
- K970159
- Product code
- FJS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-09-05
- Date received
- 1997-01-16
- Regulation
- 876.5630
- Classification name
- Catheter, Peritoneal, Long-term Indwelling
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- PAMELA L SWATKOWSKI
- Address
- 615 Enterprise St. Aurora IL US 60504 60504
FDA Registration Numbers
- 3010665433
- 9611665
- 3007544634
- 1282497
- 3007207906
- 2518902
- 3013666218
- 2030624
- 3012536737
- 9610849
- 2527072
- 9611088
- 3030574705
- 1833566
- 3009211636
- 3015225571
- 2529647
- 3015309643
- 2011171
- 1721504
- 1721676
- 1724474
- 3033589330
- 3006950086
- 1319639
- 3003915875
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10884450330149 | Flex-Neck® | Merit Medical Systems, Inc. | 2017-12-18 |
| 10884450330118 | Flex-Neck® | Merit Medical Systems, Inc. | 2017-12-18 |
| 10884450330125 | Flex-Neck® | Merit Medical Systems, Inc. | 2017-10-25 |
| 10884450330163 | Flex-Neck® | Merit Medical Systems, Inc. | 2017-10-16 |
| 10884450330156 | Flex-Neck® | Merit Medical Systems, Inc. | 2017-10-16 |
| 20884450330139 | Flex-Neck® | Merit Medical Systems, Inc. | 2017-10-16 |
| 10884450330101 | Flex-Neck® | Merit Medical Systems, Inc. | 2017-10-16 |
| 10884450330095 | Flex-Neck® | Merit Medical Systems, Inc. | 2017-10-16 |
| 10884450330170 | Flex-Neck® | Merit Medical Systems, Inc. | 2017-10-16 |
| 20884450305960 | Flex-Neck® | Merit Medical Systems, Inc. | 2017-06-15 |
| 10884450305925 | Flex-Neck® | Merit Medical Systems, Inc. | 2017-06-01 |
| 10884450305888 | Flex-Neck® | Merit Medical Systems, Inc. | 2017-05-31 |
| 10884450170349 | Flex-Neck® | Merit Medical Systems, Inc. | 2015-10-31 |
| 20884450170339 | Flex-Neck® | Merit Medical Systems, Inc. | 2015-10-31 |
| 10884450170219 | Flex-Neck® | Merit Medical Systems, Inc. | 2015-10-31 |
| 20884450170186 | Flex-Neck® | Merit Medical Systems, Inc. | 2015-10-31 |
| 10884450170325 | Flex-Neck® | Merit Medical Systems, Inc. | 2015-10-30 |
| 10884450170301 | Flex-Neck® | Merit Medical Systems, Inc. | 2015-10-30 |
| 20884450170292 | Flex-Neck® | Merit Medical Systems, Inc. | 2015-10-30 |
| 20884450170209 | Flex-Neck® | Merit Medical Systems, Inc. | 2015-10-30 |
| 10884450170196 | Flex-Neck® | Merit Medical Systems, Inc. | 2015-10-30 |
| 10884450170035 | Flex-Neck® | Merit Medical Systems, Inc. | 2015-10-30 |
Legacy Summary
summary
FDA Review
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