The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Vsi Micro-introducer Sets (regular, Stiffen), Models 7197v-7209v, 7240v-7256v, 7259v, 7230v, 7231v, 7260v, 7274v.
| Device ID | K101604 |
| 510k Number | K101604 |
| Device Name: | VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V |
| Classification | Introducer, Catheter |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Jennifer Ruether |
| Correspondent | Jennifer Ruether VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-08 |
| Decision Date | 2011-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M2067193V0 | K101604 | 000 |
| M2067219V0 | K101604 | 000 |
| M2067220V0 | K101604 | 000 |
| M2067229V0 | K101604 | 000 |
| M2067230V0 | K101604 | 000 |
| M2067230X0 | K101604 | 000 |
| M2067231V0 | K101604 | 000 |
| M2067240V0 | K101604 | 000 |
| M2067241V0 | K101604 | 000 |
| M2067242V0 | K101604 | 000 |
| M2067243V0 | K101604 | 000 |
| M2067244V1 | K101604 | 000 |
| M2067245V1 | K101604 | 000 |
| M2067246V1 | K101604 | 000 |
| M2067247V1 | K101604 | 000 |
| M2067248V1 | K101604 | 000 |
| M2067249V1 | K101604 | 000 |
| M2067250V1 | K101604 | 000 |
| M2067218V0 | K101604 | 000 |
| M2067215V0 | K101604 | 000 |
| M2067214V1 | K101604 | 000 |
| M2067194V0 | K101604 | 000 |
| M2067195V0 | K101604 | 000 |
| M2067195X0 | K101604 | 000 |
| M2067198V0 | K101604 | 000 |
| M2067199V0 | K101604 | 000 |
| M2067200V1 | K101604 | 000 |
| M2067200X0 | K101604 | 000 |
| M2067201V0 | K101604 | 000 |
| M2067202V0 | K101604 | 000 |
| M2067204V0 | K101604 | 000 |
| M2067205V0 | K101604 | 000 |
| M2067206V0 | K101604 | 000 |
| M2067207V0 | K101604 | 000 |
| M2067208V0 | K101604 | 000 |
| M2067208X0 | K101604 | 000 |
| M2067209V0 | K101604 | 000 |
| M2067210V0 | K101604 | 000 |
| M2067250X0 | K101604 | 000 |
| M2067253V1 | K101604 | 000 |
| M2067254V1 | K101604 | 000 |
| M2067273V1 | K101604 | 000 |
| M2067273X0 | K101604 | 000 |
| M2067274V1 | K101604 | 000 |
| M2067280V1 | K101604 | 000 |
| M2069200V1 | K101604 | 000 |
| M2069201V1 | K101604 | 000 |
| M2069202V1 | K101604 | 000 |
| M2069203V1 | K101604 | 000 |
| M2069208V1 | K101604 | 000 |
| M2069209V1 | K101604 | 000 |
| M2069210V1 | K101604 | 000 |
| M2069211V1 | K101604 | 000 |
| M2069217V0 | K101604 | 000 |
| M2069218V1 | K101604 | 000 |
| M2069219V1 | K101604 | 000 |
| M2069220V1 | K101604 | 000 |
| M2069221V1 | K101604 | 000 |
| M2067272X0 | K101604 | 000 |
| M2067272V1 | K101604 | 000 |
| M2067271V1 | K101604 | 000 |
| M2067255V1 | K101604 | 000 |
| M2067255X0 | K101604 | 000 |
| M2067256V1 | K101604 | 000 |
| M2067256X0 | K101604 | 000 |
| M2067259V0 | K101604 | 000 |
| M2067260V1 | K101604 | 000 |
| M2067261V1 | K101604 | 000 |
| M2067262V1 | K101604 | 000 |
| M2067263V1 | K101604 | 000 |
| M2067264V1 | K101604 | 000 |
| M2067265V1 | K101604 | 000 |
| M2067266V1 | K101604 | 000 |
| M2067267V1 | K101604 | 000 |
| M2067267X0 | K101604 | 000 |
| M2067268V1 | K101604 | 000 |
| M2067269V1 | K101604 | 000 |
| M2067270V1 | K101604 | 000 |
| M2069222V1 | K101604 | 000 |