Atlas FDA

LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES

FDA 510(k) clearance K931662 · decided 1993-08-31

Clearance details

K-number
K931662
Device name
LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES
Applicant
Pace Medical
Decision
Substantially Equivalent
Date received
1993-04-05
Decision date
1993-08-31
Days to decision
148 days
Clearance type
Traditional
Product code
DYB
Device class
2
Regulation number
870.1340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Waltham, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
NAMIC Dilator and Sheath (K253526)Medline Industries, LP2026-07-29
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) (K261529)Hartman Medical Group, LLC2026-07-06
SimplGuide (K261242)Pendracare2026-06-25
Health Line Tearaway Introducer (K261950)Health Line International Corporation2026-06-22
FieldFlex Steerable Sheath (K261492)CenterPoint Systems, LLC2026-06-05
Echo Large Bore Introducer Sheath (K260606)Echo Medical, LLC2026-04-29
Introducer Sheath Set (K254248)Cardiocycle Medical(Suzhou) Co., Ltd.2026-04-23
Edwards eSheath+ introducer set (K254279)Edwards Lifesciences2026-04-17
Aventus Introducer Sheath (K260091)Inquis Medical2026-04-13
Protaryx Transseptal Puncture Device (PTX2-001) (K260839)Protaryx Medical, Inc.2026-04-10
AuST Steerable Sheath (K260942)CenterPoint Systems, LLC2026-04-07
VANES Delivery System (VDS) (K260459)Zoll Respicardia, Inc.2026-04-06

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER (P920032/S008)Pace Medical2002-02-20
BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170 (P920032/S007)Pace Medical2001-10-26
MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER (P920032/S006)Pace Medical2001-04-06
MICRO-PACE DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER (P920032/S005)Pace Medical2000-02-02
MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER (P920032/S004)Pace Medical1998-02-27
MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER (P920032/S003)Pace Medical1996-07-19
MICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER (P920032/S002)Pace Medical1996-04-26
MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER (P920032/S001)Pace Medical1995-08-28