FDA 510(k)

COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH

K-Number: K032223 · 2003-10-15

Decision Date2003-10-15

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH is the device name listed in this FDA 510(k) record. The listed applicant is Cook Vascular, Inc.. It received FDA 510(k) clearance on 2003-10-15 under 510(k) number K032223. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH?

COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH is a medical device that received FDA 510(k) clearance on 2003-10-15. The listed applicant is Cook Vascular, Inc.. The 510(k) number is K032223.

When did COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH receive FDA 510(k) clearance?

COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH received FDA 510(k) clearance on 2003-10-15, under 510(k) number K032223.

Who is the listed applicant for COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH?

The FDA 510(k) record lists Cook Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH?

The FDA product code for COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH is GEI.

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Other records listing Cook Vascular, Inc. as applicant

K110347DOPPLER MONITOR K083482COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET K081425COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT K061000EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 K023937COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM K022649COOK-SWARTZ DOPPLER FLOW PROBE

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.