The following data is part of a premarket notification filed by Arrow International(subsidiary Of Teleflex Inc.) with the FDA for Arrow Glidethru Peel-away Sheath/dilator Introducer.
| Device ID | K122854 |
| 510k Number | K122854 |
| Device Name: | ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE RD. Reading, PA 19605 |
| Contact | Julie Lawson |
| Correspondent | Julie Lawson ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE RD. Reading, PA 19605 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-18 |
| Decision Date | 2013-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902111532 | K122854 | 000 |
| 30801902101571 | K122854 | 000 |
| 20801902201885 | K122854 | 000 |
| 20801902211976 | K122854 | 000 |
| 20801902192015 | K122854 | 000 |
| 20801902211648 | K122854 | 000 |
| 20801902211631 | K122854 | 000 |
| 20801902211617 | K122854 | 000 |
| 20801902212171 | K122854 | 000 |
| 40801902124218 | K122854 | 000 |
| 30801902080241 | K122854 | 000 |
| 30801902080258 | K122854 | 000 |
| 30801902080333 | K122854 | 000 |
| 30801902080326 | K122854 | 000 |
| 30801902080319 | K122854 | 000 |
| 30801902080302 | K122854 | 000 |
| 30801902080296 | K122854 | 000 |
| 30801902080289 | K122854 | 000 |
| 30801902080272 | K122854 | 000 |
| 30801902080265 | K122854 | 000 |
| 20801902211624 | K122854 | 000 |