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#
- 3009144177
- 3007284313
- 3007882731
- 9616088
- 1016427
- 3020968442
- 3031823122
- 3005941719
- 2032112
- 9612433
- 3008824097
- 1000121056
- 3036802499
- 9616683
- 3046772394
- 2025816
- 3007830707
- 2182269
- 2134812
- 3010432890
- 1828424
- 3006950086
- 3001374820
- 2030598
- 3011564431
- 3011137372
- 3012536737
- 3031571797
- 1721686
- 9616666
- 9611612
- 3002601200
- 1417485
- 3013666336
- 2024168
- 1224960
- 1319639
- 3011237770
- 1644312
- 3009746061
- 8010026
- 2183870
- 3009393076
- 1220648
- 3021951050
- 3010155661
- 1721676
- 1056553
- 3041086754
- 1721504
- 3015138222
- 3013162291
- 1724474
- 3025028711
- 2183744
- 1928237
- 3008500478
- 3013986346
- 3017689643
- 1319211
- 2024311
- 9681477
- 3031282706
- 3011642792
- 9612126
- 2183787
- 2953359
- 1318694
- 3010200163
- 3004785273
- 1649395
- 2015691
- 3017298588
- 3032916632
- 1820334
- 2134244
- 9612164
- 2320762
- 3010419931
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DYB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262674 | Giranel Guiding Sheath Set | Kossel Medtech (Suzhou) Co., Ltd. | 2026-10-15 |
| 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 |
Legacy Summary#
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FDA Review#
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