510(k) K931662
- Device
- LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES
- Applicant
- PACE MEDICAL
- 510(k) number
- K931662
- Product code
- DYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-08-31
- Date received
- 1993-04-05
- Regulation
- 870.1340
- Classification name
- Introducer, Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT C MACE
- Address
- 391 Totten Pond Rd. Waltham MA US 02451 02451
FDA Registration Numbers#
- 3016591327
- 3010966701
- 3010155661
- 9680794
- 9610825
- 3006082230
- 1225687
- 9673241
- 3020954746
- 3008307705
- 3000268902
- 3022815697
- 3011689956
- 1828424
- 2183787
- 3004784537
- 3007207906
- 3030446844
- 1282497
- 3035111606
- 3015225571
- 2030598
- 3009144177
- 3005168196
- 3039454510
- 3015138222
- 3001124136
- 3032916632
- 2183870
- 9616683
- 3002601200
- 3027815
- 3008261722
- 3004193842
- 3009888344
- 2015691
- 3048101437
- 1313046
- 1222140
- 3041276591
- 3019807891
- 3011752740
- 3005232773
- 3013666336
- 3008452825
- 3009437315
- 3015970743
- 3015453963
- 2024311
- 3016904853
- 1225698
- 1721676
- 3008998256
- 1220477
- 2528981
- 2182269
- 1417485
- 3006425876
- 3014687026
- 3004111573
- 9612126
- 3016678045
- 9681834
- 1220648
- 3015309643
- 3005580113
- 3004737415
- 3002808467
- 3012536737
- 3030574705
- 1625425
- 3015859709
- 1710034
- 3006131984
- 3004519921
- 2134265
- 2183744
- 1319639
- 3041086754
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DYB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253526 | NAMIC Dilator and Sheath | Medline Industries, LP | 2026-07-29 |
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) | Hartman Medical Group, LLC | 2026-07-06 |
| K261242 | SimplGuide | Pendracare | 2026-06-25 |
| K261950 | Health Line Tearaway Introducer | Health Line International Corporation | 2026-06-22 |
| K261492 | FieldFlex Steerable Sheath | CenterPoint Systems, LLC | 2026-06-05 |
| K260606 | Echo Large Bore Introducer Sheath | Echo Medical, LLC | 2026-04-29 |
| K254248 | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | 2026-04-23 |
| K254279 | Edwards eSheath+ introducer set | Edwards Lifesciences | 2026-04-17 |
| K260091 | Aventus Introducer Sheath | Inquis Medical | 2026-04-13 |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, Inc. | 2026-04-10 |
| K260942 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2026-04-07 |
| K260459 | VANES Delivery System (VDS) | Zoll Respicardia, Inc. | 2026-04-06 |
| K260626 | Multiflex Steerable Sheath 17.5F | Vizaramed, Inc. | 2026-03-26 |
| K260163 | AuST CSP Introducer | CenterPoint Systems, LLC | 2026-02-19 |
| K254236 | Peel-Away Introducer Sheath | VascuTech Medical, LLC | 2026-02-09 |
Legacy Summary#
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FDA Review#
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