BNLE Hydrophilic Jacketed Peripheral Guidewire
Biomerics Nle · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Brooklyn Park
- Advisory committee description
- Cardiovascular
- Address 1
- 10351 Xylon Ave. N., Suite 160
- Statement or summary
- Summary
- Product code
- DQX
- Zip code
- 55445
- Applicant
- Biomerics Nle
- Decision date
- 2024-05-14
- Decision code
- SESE
- Country code
- US
- Device name
- BNLE Hydrophilic Jacketed Peripheral Guidewire
- Advisory committee
- CV
- Contact
- Maggie Goshert
- K number
- K232662
- State
- MN
- Date received
- 2023-08-31
- Review advisory committee
- CV
- Postal code
- 55445
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Wire, Guide, Catheter
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1330
- Device class
- 2
- Registration number
- 3013656790, 3009600098, 3030446844, 3000268902, 9616088, 3014716786, 2953200, 1313046, 3020954746, 3009018440, 3012159165, 2527072, 3006010712, 3008837339, 3003768277, 1000523114, 9612812, 3030452144, 3007695959, 3006946276, 9617592, 3007138831, 1061124, 1055236, 3006425876, 2134285, 1226348, 2017865, 3005334138, 2134812, 2024168, 3009957947, 3042175841, 3008114965, 3009756153, 3004111573, 3033589330, 3011137372, 3013764800, 2246552 +221 more
- FEI number
- 3013656790, 3009600098, 3030446844, 3000268902, 3014716786, 1313046, 2828, 3002806565, 3009018440, 3012159165, 3020954746, 3006010712, 2527072, 3008837339, 1000523114, 3030452144, 3007695959, 1000120555, 3006946276, 3007138831, 3006425876, 2017865, 3005334138, 2024168, 3009957947, 3042175841, 3008114965, 3009756153, 3004111573, 3033589330, 3000206435, 3001236905, 3013764800, 2246552, 3001124136, 3018784828, 3030574705, 3012497308, 3002913962, 3002917664 +220 more