The following data is part of a premarket notification filed by Arrow International, Inc. (subsidiary Of Telelflex Inc.) with the FDA for Arrow Seldinger Arterial Catheterization Device 18 Ga., Arrow Seldinger Arterial Catheterization Device 20 Ga., Arrow Seldinger Arterial Catheterization Device 22 Ga., Arrow Seldinger Arterial Catheterization Device 24 Ga..
| Device ID | K171146 |
| 510k Number | K171146 |
| Device Name: | Arrow Seldinger Arterial Catheterization Device 18 Ga., Arrow Seldinger Arterial Catheterization Device 20 Ga., Arrow Seldinger Arterial Catheterization Device 22 Ga., Arrow Seldinger Arterial Catheterization Device 24 Ga. |
| Classification | Catheter, Percutaneous |
| Applicant | Arrow International, Inc. (Subsidiary Of Telelflex Inc.) 2400 Bernville Road Reading, PA 19605 |
| Contact | Fallon Young |
| Correspondent | Fallon Young Arrow International, Inc. (Subsidiary Of Telelflex Inc.) 2400 Bernville Road Reading, PA 19605 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-19 |
| Decision Date | 2017-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40801902219082 | K171146 | 000 |
| 20801902201519 | K171146 | 000 |
| 20801902201533 | K171146 | 000 |
| 20801902201540 | K171146 | 000 |
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| 20801902201403 | K171146 | 000 |
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| 20801902140962 | K171146 | 000 |
| 20801902140979 | K171146 | 000 |
| 20801902140986 | K171146 | 000 |
| 20801902140641 | K171146 | 000 |